Z-1130-03

Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0...

Name: Z-1130-03 Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-05-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-05-30 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD began a recall of Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064 on 2003-05-30. The reason FDA records is "The Free T4 Controls, may yield control values that are high and outside of the package insert ranges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1130-03
Status: Terminated
Initiated: 2003-05-30
Posted: 2003-08-13
Terminated: 2003-09-16
Recalling firm: Abbott Medical
Product: Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064
Product code: CEC Radioimmunoassay, Free Thyroxine
Reason for recall: The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made from the same raw material. The accounts were informed that the Architect Calibrator was performing as expected, but as a precaution recommended conducting a daily QC with non-Abbott Controls and to report back to Abbott any out of range non-Abbott control results.
Quantity in commerce: 3247 kits
Distribution: Nationwide and internationally to Abbott subsidiaries in Ecuador, Uruguay, Argentina, Brazil, El Salvador, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Costa Rica, Grenada, St. Lucia, Bermuda, Antigua, Panama, Guatemala, Mexico, Colombia, Jamaica, Paraguay, Peru, Chile, Dominican Republic, United Kingdom, New Zealand, Trinidad & Tabago, St. Vincent, Barbados, Curacao, St. Kitts, Anguilla, Turks & Caicos Islands, Cayman Islands, Germany and Taiwan.
Product codes and lots: List 9C03-10, lot numbers 95881Q100 and 95881Q101

Product code CEC

K934544Class IIAxsym Free Thyroxine ( Free T4 )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)