FDA Medical Device Recalls (openFDA)
Abbott Laboratories: ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
- Recall number
- Z-1660-2022
- Recalling firm
- Abbott Laboratories
- Product
- ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
- Status
- Open, Classified
- Initiated
- 2022-07-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
- 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
- 2451 kits of 100 tests
- Distribution
- Nationwide
- Lot, serial or model codes
- UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
- 510(k) numbers
- ["K041192"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28