Z-0891-2022Class II

ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the...

Name: Z-0891-2022 ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the...
Creator: Abbott Laboratories
Published: 2022-03-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-03-08 / Open, Classified / root cause: labeling and UDI

FDA source

Abbott Laboratories began a recall of ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol... on 2022-03-08. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0891-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-08
Posted: 2022-04-07
Recalling firm: Abbott Medical
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.
Product code: JIS Calibrator, Primary
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).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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).
Quantity in commerce: 402 kits
Distribution: 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
Product codes and lots: UDI: (01)00380740003272(17)220531(10)166000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0891-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0891-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-07

Product code JIS

K042924Class IIArchitect Stat Myo ImmunoassayFisher Diagnostics / cleared 2005-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)