| |
Class 2 Device Recall Alinity |
 |
| Date Initiated by Firm |
October 19, 2023 |
| Date Posted |
January 09, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0682-2024 |
| Recall Event ID |
93355 |
| Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
| Product |
ARCHITECT c4000 Processing Module REF:
02P24-01
02P24-02
02P24-40
01R24-56
01R25-56
The Abbott ARCHITECT c4000 Processing Module is designed to perform automated
chemistry tests, utilizing photometry and potentiometric technology. |
| Code Information |
List Number:
02P24-01
Serial Numbers / UDI Codes:
C400911 (01)00380740003746(21)C400911
C402913 (01)00380740003746(21)C402913
C460004 (01)00380740003746(21)C460004
C460033 (01)00380740003746(21)C460033
C460055 (01)00380740003746(21)C460055
C460066 (01)00380740003746(21)C460066
C460082 (01)00380740003746(21)C460082
C460158 (01)00380740003746(21)C460158
C460200 (01)00380740003746(21)C460200
C460375 (01)00380740003746(21)C460375
C460385 (01)00380740003746(21)C460385
C460396 (01)00380740003746(21)C460396
C460397 (01)00380740003746(21)C460397
C460408 (01)00380740003746(21)C460408
C460410 (01)00380740003746(21)C460410
C460422 (01)00380740003746(21)C460422
C460435 (01)00380740003746(21)C460435
C460439 (01)00380740003746(21)C460439
C460523 (01)00380740003746(21)C460523
C460532 (01)00380740003746(21)C460532
C460588 (01)00380740003746(21)C460588
C460728 (01)00380740003746(21)C460728
C460767 (01)00380740003746(21)C460767
C460797 (01)00380740003746(21)C460797
C460798 (01)00380740003746(21)C460798
C460800 (01)00380740003746(21)C460800
C460826 (01)00380740003746(21)C460826
C460827 (01)00380740003746(21)C460827
C460830 (01)00380740003746(21)C460830
C460832 (01)00380740003746(21)C460832
C460833 (01)00380740003746(21)C460833
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C460846 (01)00380740003746(21)C460846
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C460886 (01)00380740003746(21)C460886
C460927 (01)00380740003746(21)C460927
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C460939 (01)00380740003746(21)C460939
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C461175 (01)00380740003746(21)C461175
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C461474 (01)00380740003746(21)C461474
C461475 (01)00380740003746(21)C461475
C461476 (01)00380740003746(21)C461476
C461477 (01)00380740003746(21)C461477
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C461660 (01)00380740003746(21)C461660
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C461717 (01)00380740003746(21)C461717
C461720 (01)00380740003746(21)C461720
C461721 (01)00380740003746(21)C461721
C461723 (01)00380740003746(21)C461723
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C461751 (01)00380740003746(21)C461751
C461752 (01)00380740003746(21)C461752
C461770 (01)00380740003746(21)C461770
C461771 (01)00380740003746(21)C461771
C461772 (01)00380740003746(21)C461772
C461781 (01)00380740003746(21)C461781
C461782 (01)00380740003746(21)C461782
C461783 (01)00380740003746(21)C461783
C461800 (01)00380740003746(21)C461800
C461801 (01)00380740003746(21)C461801
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C461820 (01)00380740003746(21)C461820
C461822 (01)00380740003746(21)C461822
C461823 (01)00380740003746(21)C461823
C461835 (01)00380740003746(21)C461835
C461837 (01)00380740003746(21)C461837
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C461894 (01)00380740003746(21)C461894
C461895 (01)00380740003746(21)C461895
C461906 (01)00380740003746(21)C461906
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C462219 (01)00380740003746(21)C462219
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C462240 (01)00380740003746(21)C462240
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C462246 (01)00380740003746(21)C462246
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C462384 (01)00380740003746(21)C462384
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C462506 (01)00380740003746(21)C462506
C462536 (01)00380740003746(21)C462536
02P24-02
Serial Numbers / UDI codes:
C460391 (01)00380740081225(21)C460391
C460394 (01)00380740081225(21)C460394
C460395 (01)00380740081225(21)C460395
C460430 (01)00380740081225(21)C460430
C460434 (01)00380740081225(21)C460434
C461123 (01)00380740081225(21)C461123
02P24-40
Serial Numbers / UDI codes:
C400062 (01)00380740003753(21)C400062
C400251 (01)00380740003753(21)C400251
C400268 (01)00380740003753(21)C400268
C400288 (01)00380740003753(21)C400288
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C400404 (01)00380740003753(21)C400404
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C400445 (01)00380740003753(21)C400445
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C400491 (01)00380740003753(21)C400491
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C400689 (01)00380740003753(21)C400689
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C401025 (01)00380740003753(21)C401025
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C401052 (01)00380740003753(21)C401052
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C401161 (01)00380740003753(21)C401161
C401180 (01)00380740003753(21)C401180
C401181 (01)00380740003753(21)C401181
C401182 (01)00380740003753(21)C401182
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C401189 (01)00380740003753(21)C401189
C401199 (01)00380740003753(21)C401199
C401204 (01)00380740003753(21)C401204
C401212 (01)00380740003753(21)C401212
C401213 (01)00380740003753(21)C401213
C401214 (01)00380740003753(21)C401214
C401217 (01)00380740003753(21)C401217
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C401231 (01)00380740003753(21)C401231
C401233 (01)00380740003753(21)C401233
C401234 (01)00380740003753(21)C401234
C401237 (01)00380740003753(21)C401237
C401251 (01)00380740003753(21)C401251
C401252 (01)00380740003753(21)C401252
C401253 (01)00380740003753(21)C401253
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C401263 (01)00380740003753(21)C401263
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C401265 (01)00380740003753(21)C401265
C401275 (01)00380740003753(21)C401275
C401282 (01)00380740003753(21)C401282
C401283 (01)00380740003753(21)C401283
C401284 (01)00380740003753(21)C401284
C401289 (01)00380740003753(21)C401289
C401294 (01)00380740003753(21)C401294
C401295 (01)00380740003753(21)C401295
C401301 (01)00380740003753(21)C401301
C401321 (01)00380740003753(21)C401321
C401341 (01)00380740003753(21)C401341
C401364 (01)00380740003753(21)C401364
C401367 (01)00380740003753(21)C401367
C401368 (01)00380740003753(21)C401368
C401369 (01)00380740003753(21)C401369
C401372 (01)00380740003753(21)C401372
C401373 (01)00380740003753(21)C401373
C401387 (01)00380740003753(21)C401387
C401388 (01)00380740003753(21)C401388
C401397 (01)00380740003753(21)C401397
C401399 (01)00380740003753(21)C401399
C401405 (01)00380740003753(21)C401405
C401406 (01)00380740003753(21)C401406
C401408 (01)00380740003753(21)C401408
C401409 (01)00380740003753(21)C401409
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C401435 (01)00380740003753(21)C401435
C401452 (01)00380740003753(21)C401452
C401453 (01)00380740003753(21)C401453
C401456 (01)00380740003753(21)C401456
C401463 (01)00380740003753(21)C401463
C401468 (01)00380740003753(21)C401468
C401470 (01)00380740003753(21)C401470
C401484 (01)00380740003753(21)C401484
C401485 (01)00380740003753(21)C401485
C401486 (01)00380740003753(21)C401486
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C402851 (01)00380740003753(21)C402851
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C402853 (01)00380740003753(21)C402853
C402854 (01)00380740003753(21)C402854
C402855 (01)00380740003753(21)C402855
C402856 (01)00380740003753(21)C402856
C402864 (01)00380740003753(21)C402864
C402865 (01)00380740003753(21)C402865
C402866 (01)00380740003753(21)C402866
C402867 (01)00380740003753(21)C402867
C402868 (01)00380740003753(21)C402868
C402895 (01)00380740003753(21)C402895
C402896 (01)00380740003753(21)C402896
C402898 (01)00380740003753(21)C402898
C402899 (01)00380740003753(21)C402899
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C402901 (01)00380740003753(21)C402901
C402902 (01)00380740003753(21)C402902
C402903 (01)00380740003753(21)C402903
C402904 (01)00380740003753(21)C402904
C402911 (01)00380740003753(21)C402911
C402912 (01)00380740003753(21)C402912
C402914 (01)00380740003753(21)C402914
C402938 (01)00380740003753(21)C402938
C402939 (01)00380740003753(21)C402939
C402940 (01)00380740003753(21)C402940
C402941 (01)00380740003753(21)C402941
C402953 (01)00380740003753(21)C402953
C402954 (01)00380740003753(21)C402954
C402955 (01)00380740003753(21)C402955
C402956 (01)00380740003753(21)C402956
C402958 (01)00380740003753(21)C402958
C402959 (01)00380740003753(21)C402959
C402960 (01)00380740003753(21)C402960
C402961 (01)00380740003753(21)C402961
C402962 (01)00380740003753(21)C402962
C402963 (01)00380740003753(21)C402963
C402982 (01)00380740003753(21)C402982
C402983 (01)00380740003753(21)C402983
C402985 (01)00380740003753(21)C402985
C402996 (01)00380740003753(21)C402996
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C402998 (01)00380740003753(21)C402998
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C403019 (01)00380740003753(21)C403019
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C403156 (01)00380740003753(21)C403156
C403174 (01)00380740003753(21)C403174
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C403186 (01)00380740003753(21)C403186
C403187 (01)00380740003753(21)C403187
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C403191 (01)00380740003753(21)C403191
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C403202 (01)00380740003753(21)C403202
C403203 (01)00380740003753(21)C403203
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C403221 (01)00380740003753(21)C403221
C403224 (01)00380740003753(21)C403224
C403226 (01)00380740003753(21)C403226
C403227 (01)00380740003753(21)C403227
C403228 (01)00380740003753(21)C403228
C403262 (01)00380740003753(21)C403262
C403310 (01)00380740003753(21)C403310
C460089 (01)00380740003753(21)C460089
C460433 (01)00380740003753(21)C460433
01R24-56
01R25-56
Serial Numbers and UDI codes were not provided. These two products were only distributed O.U.S. (Brazil) |
Recalling Firm/
Manufacturer |
Abbott Laboratories
1915 Hurd Dr
Irving TX 75038-4313
|
| For Additional Information Contact |
Suchin Song
224-668-0343
|
Manufacturer Reason
for Recall |
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On 10/19/2023, the firm sent an "Urgent Medical Device Correction" Letter via FedEx priority overnight express to customers informing them that Abbott has determined that, A labeling update is required for the products listed above to meet US regulatory requirement 21 CFR 801.437 (User labeling for devices that contain natural rubber) and Brazilian requirement RDC 37/2015 (medical devices and IVDs to include in the label a Standardized Latex Warning in Portuguese CONTAIN NATURAL LATEX. MAY CAUSE ALLERGIES ). These Abbott products include internal hardware parts and/or subassemblies that contain dry natural rubber (latex) which may cause allergic reactions, but do not include the required precautionary label. Additionally, the Alinity s System Solid Waste Container Rubber Band (LN 04U97-01), used to secure the biohazard bag to the solid waste container, contains dry natural rubber (latex).
Customer are instructed to:
1) Follow good laboratory practice by wearing impervious gloves and other personal protective equipment when working on the above listed Abbott product(s).
2) If you have forwarded the product(s) listed above to other laboratories, please inform them of this Product Correction and provide a copy of this letter.
3) Please retain this letter for your laboratory records.
A precautionary label will be applied to the affected products. An Abbott representative will schedule a service visit when the instrument label is available for application.
For questions or concerns, contact Customer Service at 1-877-4ABBOTT (24 hr/7 days a week). |
| Quantity in Commerce |
995 systems |
| Distribution |
U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV
O.U.S.: Brazil |
| 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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