—#192442

Product

ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

FDA product code: JIS — Calibrator, Primary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K042924
Affected lot / code info: UDI: (01)00380740003272(17)220531(10)166000

Why it was recalled

This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Abbott, notified their consignees by "Urgent Medical Device Products Recall" letter on 03/08/2022. The letter explained the issue and requested the use of the affected item be discontinued and destroyed, and the Customer Reply Form be completed and returned via FAX #: 1-800-777-0051 or email PMS@abbott.com. The firm is replacing the product. If you or any of the health care providers you serve have questions regarding this information, U.S. Customers 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: Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG, MACEDONIA, MOROCCO, PANAMA, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, and TURKEY

Timeline

Recall initiated: 2022-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.