Abbott Laboratories 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
UDI: (01)00380740003272(17)220531(10)166000
Products Sold
UDI: (01)00380740003272(17)220531(10)166000
Abbott Laboratories is recalling ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for due to This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026