Z-1660-2022Class II

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Name: Z-1660-2022 ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Creator: Abbott Laboratories
Published: 2022-07-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-07-26 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 on 2022-07-26. FDA classified it as Class II and gives the reason as "One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1660-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-26
Posted: 2022-08-30
Recalling firm: Abbott Medical
Product: ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1660-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1660-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-30

Product code MMI

K041192Class IIArchitect Stat Troponin-I ImmunoassayFisher Diagnostics / cleared 2004-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)