ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
FDA Recall Z-1660-2022 · Posted None
Recalling FirmAbbott Laboratories
Recall StatusOpen, Classified
Product CodeMMI
Date Initiated2022-07-26
Product Quantity2451 kits of 100 tests
Reason for Recall
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
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).
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.