| Class 2 Device Recall ARCHITECT cSystems | |
Date Initiated by Firm | September 29, 2021 |
Create Date | November 19, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0272-2022 |
Recall Event ID |
88880 |
510(K)Number | K983212 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25;
ARCHITECT c8000 REF 01G06-11/1G06;
ARCHITECT c16000 REF 03L77-01/3L77; |
Code Information |
Product Description/List Number
ARCHITECT c4000
Module List Number: 2P24
UDI: (01)00380740003746(21)c4123456(240)02P2401
Serial Numbers:
C400000
C400010
C400011
C400012
C400013
c400014
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C462015
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C462017
C462018
C462019
C462020
C462021
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C462161
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C462178
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C462194
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C462196
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c462198
C462201
c462202
c462204
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C462206
C462207
C462208
C462210
C462212
C462213
C462214
C462215
C462216
C462217
C462218
C462219
C462220
C462221
C462222
C462233
C462234
c462235
C462236
C462237
c462238
C462239
C462240
C462241
c462242
c462243
C462244
C462245
C462246
C462247
C462248
C462250
C462252
c462253
C462254
C462255
C462256
C462257
c462261
C462263
C462264
C462265
C462266
C462267
C462268
C462269
C462272
c462273
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C462276
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C462278
C462279
C462280
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C462288
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C462298
C462299
C462300
C462302
C462314
C462315
C462318
C462319
Module List Number: 1P86
Serial Numbers:
C400059
C401015
C401034
C401578
C401634
C402381
C460036
C460294
c460407
C460533
c460694
c461591
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c461605
c461671
c461753
c461777
c461779
c461788
c461824
c461845
c461891
c461892
c462199
Module List Number: 1R24
Serial Numbers:
C400037
C400110
C400194
C400763
C460013
C460015
C460027
C460028
C460039
C460045
C460054
C460058
C460094
C460104
C460157
C460168
C460171
C460205
C460206
C460223
C460225
C460262
C460289
C460300
C460331
C460339
C460358
C460363
C460377
C460382
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C460404
C460412
C460413
C460448
C460459
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C460481
C460487
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C460503
C460504
C460575
C460609
C460644
C460655
C460665
C460749
C460754
C460755
C460771
C460823
C460851
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C460864
C460867
C460893
C460962
C461059
C461106
C461116
C461157
C461201
C461203
C461234
C461239
C461240
C461241
C461253
C461255
C461293
C461294
C461296
C461301
C461302
C461310
C461315
C461318
C461326
C461387
C461397
C461406
C461465
C461681
Module List Number: 1R25
Serial Numbers:
C400033
C400048
C400052
C400076
C400082
C400088
C400094
C400097
C400103
C400111
C400113
C400126
C400128
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C400180
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C400193
C400198
C400208
C400216
C400219
C400221
C400225
C400226
C400233
C400249
C400255
C400257
C400265
C400267
C400272
C400286
C400308
C400311
C400314
C400323
C400330
C400336
C400339
C400343
C400353
C400360
C400361
c400372
C400396
C400401
C400421
C400438
C400441
C400452
C400458
C400462
C400506
C400507
C400517
C400553
C400592
C400613
C400615
C400628
C400644
C400674
C400698
C400738
C400774
C400783
C400788
C400808
C400833
C400865
C400868
C400878
C400894
C400918
C400924
C400942
C400950
C400990
C401035
C401040
C401068
C401096
C401111
C401122
C401123
C401136
C401184
C401346
C401350
C401374
C401410
C401427
C401445
C401497
C401501
C401511
C401657
C401803
C401812
C401862
C401939
C460037
C460079
C460369
C460427
C460786
C460934
ARCHITECT c8000
Module List Number: 1G06
Serial Numbers:
C800019
C800031
C800038
C800040
C800041
C800044
C800048
C800049
C800052
C800054
C800057
C800059
C800061
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C800100
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C800111
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C800132
C800133
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C800135
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C800137
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C800139
C800140
C800141
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C800143
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C800145
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C800148
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C800180
C800181
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C800183
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C800185
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C800187
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C800189
C800190
C800191
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C800193
C800194
C800195
C800196
C800197
C800198
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C800200
C800201
C800202
C800203
C800204
C800205
C800206
C800207
C800208
C800209
C800210
C800211
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C800213
C800214
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C800216
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C800218
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C800220
C800221
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C800223
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C800225
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C800230
C800231
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C800233
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C800260
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C800265
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C800276
C800277
C800278
C800279
C800280
C800281
C800282
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C800284
C800285
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C800287
C800288
C800289
C800290
C800291
C800292
C800293
C800294
C800295
C800296
C800297
C800298
C800299
C800300
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C800302
C800303
C800304
C800305
C800306
C800307
C800308
C800309
C800310
C800311
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C800313
C800314
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C800316
C800317
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C800319
C800320
C800321
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C800323
C800324
C800325
C800326
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C800328
C800329
C800330
C800331
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C800333
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C800336
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C800339
C800340
C800341
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C800349
C800350
C800351
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C800355
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C800360
C800361
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C800365
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C800373
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C800379
C800380
C800381
C800382
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C800384
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C800388
C800389
C800390
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C800392
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C800394
C800395
C800396
C800397
C800398
C800399
C800400
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C800402
C800403
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C800405
C800406
C800407
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C800410
C800411
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C800421
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C800425
C800426
C800427
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C800434
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C800439
C800440
C800441
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C800476
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C800481
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C800491
C800492
C800493
C800494
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C800496
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C800499
C800500
C800501
C800502
C800503
C800504
C800505
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C800507
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C800509
C800510
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C800514
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C800520
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C800522
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C800524
C800525
C800526
C800527
C800528
C800529
C800530
C800531
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C800533
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C800536
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C800542
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C800545
C800546
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C800551
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C800560
C800561
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C800566
C800567
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C800569
C800570
C800571
C800572
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C800574
C800575
C800576
C800577
C800578
C800579
C800580
C800581
C800582
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C800584
C800585
C800586
C800587
C800588
C800589
C800590
C800591
C800592
C800593
C800594
C800595
C800596
C800597
C800598
C800599
C800600
C800601
C800602
C800603
C800604
C800605
C800606
C800607
C800608
C800609
C800610
C800611
C800612
C800613
C800614
C800615
C800616
C800617
C800618
C800619
C800620
C800621
C800622
C800623
C800624
C800625
C800626
C800627
C800628
C800629
C800630
C800631
C800632
C800633
C800634
C800635
C800636
C800637
C800638
C800639
C800640
C800641
C800642
C800643
C800644
C800645
C800646
C800647
C800648
C800649
C800650
C800651
C800652
C800653
C800654
C800655
C800656
C800657
C800658
C800659
C800660
C800661
C800662
C800663
C800664
C800665
C800666
C800667
C800668
C800669
C800670
C800671
C800672
C800673
C800674
C800675
C800676
C800677
C800678
C800679
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ARCHITECT c16000
Module List Number: 3L77
UDI: (01)00380740005924(21)C16123456(240)03L7701
Serial Numbers:
C1600014
C1600015
C1600016
C1600017
C1600024
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c1601898
c1601899
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C1601903
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c1601926
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c1601967
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C1602000
C1602001
C1602002
C1602003
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C1602008
C1602009
C1602010
C1602011
C1602012
C1602013
C1602014
C1602015
C1602016
C1602017
C1602018
C1602019
C1602020
c1602021
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c1602100
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C1602105
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C1602107
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C1602109
C1602110
C1602111
C1602112
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C1602149
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c1602151 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 1915 Hurd Dr Irving TX 75038
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For Additional Information Contact | Dana Dominguez Schmidt 224-667-8598 |
Manufacturer Reason for Recall | Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes. |
FDA Determined Cause 2 | Software design |
Action | On 09/29/2021, the Firm issued an "Urgent Medical Device Correction" Notification Letter via FedEx priority overnight express informing customers that the Firm has identified 3 potential performance issues with Software version 9.41 and earlier. The 3 issues are:
1. When an Error Code 3382, Unable to process test, internal wash pressure (x) error (y)
pipettor occurs, the systems are incorrectly placed into a Scheduled Pause status rather than a Stopped status. As a result, the processing module continues to process tests after the hardware error is detected. This may cause incorrect results to be generated.
2. When configuring a Calibrator Sample Volume on the Configure Assays screen, if the
user selects multiple assays, the calibrator sample volume from one assay may be
carried into the calibrator sample volume for another assay. Incorrect calibrator sample
volumes have the potential to generate incorrect calibration curves which may lead to
incorrect results and delay of results due to the need to reconfigure assay parameters.
3. When performing a backup on the system while the iARM is replenishing the wash
buffer at the same time, the iARM looses communication with the System Control Center.
The loss of communication may cause the wash buffer container to overflow. This has
the potential to lead to physical and chemical hazards.
Customers are instructed to follow the Necessary Actions listed in Appendix A until software version 9.45 or software version 9.50 are installed.
Appendix A states:
For Issue (listed above):
#1-The Necessary Actions to be taken by the customers until mandatory upgrade is completed - Stop the processing module and discard any results produced after
an Error Code 3382. Perform Corrective Actions for Error Code 3382. For details, refer to System Operations Manual, Section 10: Troubleshooting and diagnostics.
#2-The Necessary Actions to be taken by the customers until mandatory upgrade is completed - Verify the correct calibrator sample v |
Quantity in Commerce | 7,535 systems |
Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
O.U.S.: AFGHANISTAN
ALBANIA,
ALGERIA,
ANDORRA,
ANGOLA,
ARGENTINA,
ARMENIA,
AUSTRALIA,
AUSTRIA,
AZERBAIJAN,
BAHAMAS,
BAHRAIN,
BANGLADESH,
BARBADOS,
BELARUS,
BELGIUM,
BELIZE,
BENIN,
BERMUDA,
BOLIVIA,
BOSNIA AND HERZEGOVINA,
BOTSWANA,
BRAZIL,
BRUNEI,
BULGARIA,
BURKINA FASO,
BURUNDI,
CAMBODIA,
CAMEROON,
CANADA,
CAYMAN ISLANDS,
CHILE,
CHINA,
COLOMBIA,
COSTA RICA,
CROATIA,
CYPRUS,
CZECH REPUBLIC,
DEMOCRATIC REP. OF CONGO,
DENMARK,
FAROE ISLANDS,
DOMINICAN REPUBLIC,
ECUADOR,
EGYPT,
EL SALVADOR,
ERITREA,
ESTONIA,
ETHIOPIA,
FINLAND,
FRANCE,
GEORGIA,
GERMANY,
GHANA,
GREECE,
GREENLAND,
GUATEMALA,
GUINEA,
HAITI,
HONDURAS,
HONG KONG,
HUNGARY,
ICELAND,
INDIA,
INDONESIA,
IRAN,
IRAQ,
IRELAND,
ISRAEL,
ITALY,
IVORY COAST,
JAMAICA,
JAPAN,
JORDAN,
KAZAKHSTAN,
KENYA,
KUWAIT,
KYRGYZSTAN,
LATVIA,
LEBANON,
LIBYA,
LITHUANIA,
LUXEMBOURG,
MACEDONIA,
MADAGASCAR,
MALAWI,
MALAYSIA,
MALDIVES,
MALI,
MALTA,
MAURITANIA,
MAURITIUS,
MEXICO,
MOLDOVA,
MONTENEGRO,
MONTSERRAT,
MOROCCO,
MOZAMBIQUE,
MYANMAR,
NAMIBIA,
NEPAL,
NETHERLANDS,
NEW CALEDONIA,
NEW ZEALAND,
NICARAGUA,
NIGERIA,
NORWAY,
OMAN,
PAKISTAN,
PANAMA,
PARAGUAY,
PERU,
PHILIPPINES,
POLAND,
PORTUGAL,
QATAR,
ROMANIA,
RUSSIA,
RWANDA,
SAUDI ARABIA,
SENEGAL,
SERBIA,
SINGAPORE,
SLOVAKIA,
SLOVENIA,
SOUTH AFRICA,
SOUTH KOREA,
SPAIN,
SRI LANKA,
ST. LUCIA,
ST. VINCENT,
SURINAME,
SWEDEN,
SWITZERLAND,
SYRIA,
TAIWAN,
TAJIKISTAN,
TANZANIA,
THAILAND,
TRINIDAD & TOBAGO,
TUNISIA,
TURK & CAICOS,
TURKEY,
UAE,
UGANDA,
UK,
UKRAINE,
URUGUAY,
UZBEKISTAN,
VIETNAM,
WEST BANK/GAZA STRIP,
YEMEN,
ZAMBIA,
ZIMBABWE, |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JJE
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