Z-0400-06

ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from...

Name: Z-0400-06 ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from...
Creator: Abbott Laboratories MPG
Published: 2005-10-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-10-17 / Terminated

FDA source

Abbott Laboratories MPG began a recall of ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories... on 2005-10-17. The reason FDA records is "Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0400-06
Status: Terminated
Initiated: 2005-10-17
Posted: 2006-01-18
Terminated: 2006-05-25
Recalling firm: Abbott Medical
Product: ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Product code: DDR Myoglobin, Antigen, Antiserum, Control
Reason for recall: Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.
FDA root cause: Other
Action: Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. However, long term use of this kit may result in calibration failures or controls out of range. The accounts were requested to mark the kit(s) of this lot currently in inventory to distinguish them from the replacement kit(s) Abbott will be sending to them. As a precaution, Abbott requested the labs to discontinue use of these kits and destroy them the replacement kits are received.
Quantity in commerce: 11 kits
Distribution: Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea
Product codes and lots: list 02K43-01, lot number V96128

Product code DDR

K042920Class IIHoveround Se-3 PowerchairHoveround Corp. / cleared 2004-12-03

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)