|
Class 2 Device Recall Alinity |
|
Date Initiated by Firm |
October 19, 2023 |
Date Posted |
January 09, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0681-2024 |
Recall Event ID |
93355 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
Alinity c Processing Module REF 03R67-01
The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes). |
Code Information |
List Number: 03R67-01
Serial Numbers / UDI-DI codes (U.S. systems):
AC01225 (01)00380740137380(21)AC01225
AC01226 (01)00380740137380(21)AC01226
AC01256 (01)00380740137380(21)AC01256
AC01257 (01)00380740137380(21)AC01257
AC01263 (01)00380740137380(21)AC01263
AC01264 (01)00380740137380(21)AC01264
AC01273 (01)00380740137380(21)AC01273
AC01274 (01)00380740137380(21)AC01274
AC01275 (01)00380740137380(21)AC01275
AC01356 (01)00380740137380(21)AC01356
AC01357 (01)00380740137380(21)AC01357
AC01358 (01)00380740137380(21)AC01358
AC01503 (01)00380740137380(21)AC01503
AC01504 (01)00380740137380(21)AC01504
AC01505 (01)00380740137380(21)AC01505
AC01506 (01)00380740137380(21)AC01506
AC01507 (01)00380740137380(21)AC01507
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AC01518 (01)00380740137380(21)AC01518
AC01521 (01)00380740137380(21)AC01521
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Recalling Firm/ Manufacturer |
Abbott Laboratories 1915 Hurd Dr Irving TX 75038-4313
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For Additional Information Contact |
Suchin Song 224-668-0343
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Manufacturer Reason for Recall |
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
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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 |
1,127 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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