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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott ARCHITECT

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  Class 2 Device Recall Abbott ARCHITECT see related information
Date Initiated by Firm July 26, 2022
Create Date August 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-1660-2022
Recall Event ID 90692
510(K)Number K041192  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Code Information UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd Bldg Ap8b
Abbott Park IL 60064-3502
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall		 One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
FDA Determined
Cause 2		 Under Investigation by firm
Action On July 26, 2022, Abbott issued a Product Recall letter for this issue sent the letter via FedEx priority overnight express. The letter provided the reason for the recall and hazard involved and requested the consignee take the following actions: "" IMMEDIATELY discontinue use of ARCHITECT STAT Troponin-I, List Number 2K41-27 lot number 63718UN22 and destroy all inventory of lot 63718UN22 according to your laboratory procedures. " Please contact Customer Support to order replacement material. " Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for review of previously reported patient results using lot number 63718UN22. " Complete and return the Customer Reply Form. " If you have forwarded the product listed above to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter. " Please retain this letter for your laboratory records." Questions regarding the information were provided the following contact information: If you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).
Quantity in Commerce 2451 kits of 100 tests
Distribution Nationwide
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.
510(K) Database 510(K)s with Product Code = MMI and Original Applicant = FISHER DIAGNOSTICS
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