Z-0023-2007

Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use

Name: Z-0023-2007 Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use
Creator: Abbott Diagnostic International, Ltd.
Published: 2006-09-07
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2006-09-07 / Terminated / root cause: manufacturing process

FDA source

Abbott Diagnostic International, Ltd. began a recall of Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use on 2006-09-07. The reason FDA records is "Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0023-2007
Status: Terminated
Initiated: 2006-09-07
Posted: 2006-10-12
Terminated: 2011-09-09
Recalling firm: Abbott Diagnostic International, Ltd.
Product: Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Product code: JIS Calibrator, Primary
Reason for recall: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.
Quantity in commerce: 797
Distribution: Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.
Product codes and lots: Lot# 33266Q100 Expiration Date 11/04/2006

Product code JIS

K935612Class IAxsym Follicle Stimulating Hormone (Fsh)Abbott Laboratories / cleared 1994-06-21

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)