Z-0353-04

ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and...

Name: Z-0353-04 ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-12-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-12-15 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL... on 2003-12-15. The reason FDA records is "The calibrator lots may yield Free T4 values that are depressed". 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-0353-04
Status: Terminated
Initiated: 2003-12-15
Posted: 2004-07-20
Terminated: 2004-07-22
Recalling firm: Abbott Medical
Product: ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
Product code: CEC--
Reason for recall: The calibrator lots may yield Free T4 values that are depressed.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Architect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product.
Quantity in commerce: 1,364 kits
Distribution: Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan.
Product codes and lots: lots 94493M300 and 94493M301

Product code CEC--

K983417Class IIAbbott Architect Free T4Abbott Laboratories / cleared 1998-11-20

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)