ARCHITECT recallZ-1660-2022 · Abbott Laboratories · initiated Jul 26, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-1660-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2022
- Recalling firm
- Abbott Laboratories
- Quantity
- 2451 kits of 100 tests
- Product code
- MMI
- FDA submissions
- K041192
- Distribution
- Nationwide
Product description
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Code information (models, lots, serial numbers)
UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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