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 Recall Z-0891-2022 · Posted None
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Recalling FirmAbbott Laboratories
Recall StatusOpen, Classified
Product CodeJIS
Date Initiated2022-03-08
Product Quantity402 kits
Reason for Recall
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).
Firm Action
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 [email protected]. 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).
Root Cause
Under Investigation by firm
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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