| |
Class 2 Device Recall Alinity |
 |
| Date Initiated by Firm |
October 19, 2023 |
| Date Posted |
January 09, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0680-2024 |
| Recall Event ID |
93355 |
| Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
| Product |
Alinity i Processing Module REF 03R65-01
The Alinity i Processing Module is a fully automated immunoassay analyzer allowing
random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. |
| Code Information |
List Number: 03R65-01
Serial Numbers / UDI-DI codes (for U.S. systems only):
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AI25042 (01)00380740137366(21)AI25042
AI25054 (01)00380740137366(21)AI25054
AI25058 (01)00380740137366(21)AI25058
AI25059 (01)00380740137366(21)AI25059
AI25065 (01)00380740137366(21)AI25065
AI25073 (01)00380740137366(21)AI25073
AI25132 (01)00380740137366(21)AI25132
AI25138 (01)00380740137366(21)AI25138
AI25141 (01)00380740137366(21)AI25141
AI25203 (01)00380740137366(21)AI25203
AI25204 (01)00380740137366(21)AI25204
AI25206 (01)00380740137366(21)AI25206
AI25207 (01)00380740137366(21)AI25207
AI25208 (01)00380740137366(21)AI25208
AI25214 (01)00380740137366(21)AI25214
AI25216 (01)00380740137366(21)AI25216
AI25219 (01)00380740137366(21)AI25219
AI25254 (01)00380740137366(21)AI25254
AI25257 (01)00380740137366(21)AI25257
AI25261 (01)00380740137366(21)AI25261
AI25262 (01)00380740137366(21)AI25262
AI25276 (01)00380740137366(21)AI25276
AI25336 (01)00380740137366(21)AI25336
AI25339 (01)00380740137366(21)AI25339
AI25342 (01)00380740137366(21)AI25342
AI25358 (01)00380740137366(21)AI25358
AI25360 (01)00380740137366(21)AI25360
AI25366 (01)00380740137366(21)AI25366
AI25368 (01)00380740137366(21)AI25368
AI25369 (01)00380740137366(21)AI25369
AI25371 (01)00380740137366(21)AI25371
AI25373 (01)00380740137366(21)AI25373
AI25384 (01)00380740137366(21)AI25384
AI25385 (01)00380740137366(21)AI25385
AI25439 (01)00380740137366(21)AI25439
AI25451 (01)00380740137366(21)AI25451
AI25460 (01)00380740137366(21)AI25460
AI25461 (01)00380740137366(21)AI25461
AI25462 (01)00380740137366(21)AI25462
AI25463 (01)00380740137366(21)AI25463
AI25478 (01)00380740137366(21)AI25478
AI25484 (01)00380740137366(21)AI25484
AI25524 (01)00380740137366(21)AI25524
AI25526 (01)00380740137366(21)AI25526
AI25528 (01)00380740137366(21)AI25528
AI25536 (01)00380740137366(21)AI25536
AI25537 (01)00380740137366(21)AI25537
AI25539 (01)00380740137366(21)AI25539
AI25540 (01)00380740137366(21)AI25540
AI25541 (01)00380740137366(21)AI25541
AI25542 (01)00380740137366(21)AI25542
AI25543 (01)00380740137366(21)AI25543
AI25544 (01)00380740137366(21)AI25544
AI25545 (01)00380740137366(21)AI25545
AI25547 (01)00380740137366(21)AI25547
AI25549 (01)00380740137366(21)AI25549
AI25555 (01)00380740137366(21)AI25555
AI25566 (01)00380740137366(21)AI25566
AI25612 (01)00380740137366(21)AI25612
AI25658 (01)00380740137366(21)AI25658
AI25660 (01)00380740137366(21)AI25660
AI25661 (01)00380740137366(21)AI25661
AI25662 (01)00380740137366(21)AI25662
AI25663 (01)00380740137366(21)AI25663
AI25664 (01)00380740137366(21)AI25664
AI25666 (01)00380740137366(21)AI25666
AI25667 (01)00380740137366(21)AI25667
AI25668 (01)00380740137366(21)AI25668
AI25669 (01)00380740137366(21)AI25669
AI25670 (01)00380740137366(21)AI25670
AI25671 (01)00380740137366(21)AI25671
AI25672 (01)00380740137366(21)AI25672
AI25676 (01)00380740137366(21)AI25676
AI25677 (01)00380740137366(21)AI25677
AI25738 (01)00380740137366(21)AI25738
AI25741 (01)00380740137366(21)AI25741
AI25748 (01)00380740137366(21)AI25748
AI25751 (01)00380740137366(21)AI25751
AI25753 (01)00380740137366(21)AI25753
AI25754 (01)00380740137366(21)AI25754
AI25756 (01)00380740137366(21)AI25756
AI25759 (01)00380740137366(21)AI25759
AI25761 (01)00380740137366(21)AI25761
AI25762 (01)00380740137366(21)AI25762
AI25764 (01)00380740137366(21)AI25764
AI25765 (01)00380740137366(21)AI25765
AI25768 (01)00380740137366(21)AI25768
AI25769 (01)00380740137366(21)AI25769
AI25777 (01)00380740137366(21)AI25777
AI25779 (01)00380740137366(21)AI25779
AI25780 (01)00380740137366(21)AI25780
AI25788 (01)00380740137366(21)AI25788
AI25798 (01)00380740137366(21)AI25798
AI25844 (01)00380740137366(21)AI25844
AI25851 (01)00380740137366(21)AI25851
AI25854 (01)00380740137366(21)AI25854
AI25863 (01)00380740137366(21)AI25863
AI25864 (01)00380740137366(21)AI25864
AI25867 (01)00380740137366(21)AI25867
AI25868 (01)00380740137366(21)AI25868
AI25871 (01)00380740137366(21)AI25871
AI25873 (01)00380740137366(21)AI25873
AI25874 (01)00380740137366(21)AI25874
AI25875 (01)00380740137366(21)AI25875
AI25876 (01)00380740137366(21)AI25876
AI25883 (01)00380740137366(21)AI25883
AI25884 (01)00380740137366(21)AI25884
AI25885 (01)00380740137366(21)AI25885
AI25886 (01)00380740137366(21)AI25886
AI25887 (01)00380740137366(21)AI25887
AI25888 (01)00380740137366(21)AI25888
AI25889 (01)00380740137366(21)AI25889
AI25890 (01)00380740137366(21)AI25890
AI25892 (01)00380740137366(21)AI25892
AI25901 (01)00380740137366(21)AI25901
AI25903 (01)00380740137366(21)AI25903
AI25919 (01)00380740137366(21)AI25919
AI25924 (01)00380740137366(21)AI25924
AI25932 (01)00380740137366(21)AI25932
AI25936 (01)00380740137366(21)AI25936
AI25938 (01)00380740137366(21)AI25938
AI25941 (01)00380740137366(21)AI25941
AI25942 (01)00380740137366(21)AI25942
AI25946 (01)00380740137366(21)AI25946
AI25972 (01)00380740137366(21)AI25972
AI25994 (01)00380740137366(21)AI25994
AI26013 (01)00380740137366(21)AI26013
AI26014 (01)00380740137366(21)AI26014
AI26015 (01)00380740137366(21)AI26015
AI26021 (01)00380740137366(21)AI26021
AI26025 (01)00380740137366(21)AI26025
AI26028 (01)00380740137366(21)AI26028
AI26034 (01)00380740137366(21)AI26034
AI26035 (01)00380740137366(21)AI26035
AI26038 (01)00380740137366(21)AI26038
AI26039 (01)00380740137366(21)AI26039
AI26042 (01)00380740137366(21)AI26042
AI26043 (01)00380740137366(21)AI26043
AI26045 (01)00380740137366(21)AI26045
AI26046 (01)00380740137366(21)AI26046
AI26049 (01)00380740137366(21)AI26049
AI26051 (01)00380740137366(21)AI26051
AI26058 (01)00380740137366(21)AI26058
AI26062 (01)00380740137366(21)AI26062
AI26067 (01)00380740137366(21)AI26067
AI26068 (01)00380740137366(21)AI26068
AI26074 (01)00380740137366(21)AI26074
AI26075 (01)00380740137366(21)AI26075
AI26088 (01)00380740137366(21)AI26088
AI26122 (01)00380740137366(21)AI26122
AI26123 (01)00380740137366(21)AI26123
AI26124 (01)00380740137366(21)AI26124
AI26126 (01)00380740137366(21)AI26126
AI26127 (01)00380740137366(21)AI26127
AI26128 (01)00380740137366(21)AI26128
AI26131 (01)00380740137366(21)AI26131
AI26133 (01)00380740137366(21)AI26133
AI26139 (01)00380740137366(21)AI26139
AI26140 (01)00380740137366(21)AI26140
AI26142 (01)00380740137366(21)AI26142
AI26145 (01)00380740137366(21)AI26145
AI26156 (01)00380740137366(21)AI26156
AI26162 (01)00380740137366(21)AI26162
AI26165 (01)00380740137366(21)AI26165
AI26172 (01)00380740137366(21)AI26172
AI26173 (01)00380740137366(21)AI26173
AI26175 (01)00380740137366(21)AI26175
AI26179 (01)00380740137366(21)AI26179
AI26186 (01)00380740137366(21)AI26186
AI26191 (01)00380740137366(21)AI26191
AI26194 (01)00380740137366(21)AI26194
AI26196 (01)00380740137366(21)AI26196
AI26197 (01)00380740137366(21)AI26197
AI26199 (01)00380740137366(21)AI26199
AI26229 (01)00380740137366(21)AI26229
AI26232 (01)00380740137366(21)AI26232
AI26237 (01)00380740137366(21)AI26237
AI26240 (01)00380740137366(21)AI26240
AI26241 (01)00380740137366(21)AI26241
AI26242 (01)00380740137366(21)AI26242
AI26247 (01)00380740137366(21)AI26247
AI26249 (01)00380740137366(21)AI26249
AI26250 (01)00380740137366(21)AI26250
AI26251 (01)00380740137366(21)AI26251
AI26252 (01)00380740137366(21)AI26252
AI26254 (01)00380740137366(21)AI26254
AI26259 (01)00380740137366(21)AI26259
AI26261 (01)00380740137366(21)AI26261
|
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 |
1,325 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
|
|
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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