—#195435

Product

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

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K041192
Affected lot / code info: UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22

Why it was recalled

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195435. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.