Z-0782-03

Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a...

Name: Z-0782-03 Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-03-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-03-31 / Terminated

FDA source

Abbott Laboratories HPD/ADD began a recall of Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL... on 2003-03-31. The reason FDA records is "Lot gives lower specimen results compared to results generated with other lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0782-03
Status: Terminated
Initiated: 2003-03-31
Posted: 2003-04-24
Terminated: 2003-08-19
Recalling firm: Abbott Medical
Product: Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Product code: JLS Radioimmunoassay, Progesterone
Reason for recall: Lot gives lower specimen results compared to results generated with other lots.
FDA root cause: Other
Action: Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.
Quantity in commerce: 368 kits
Distribution: Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore
Product codes and lots: list 6C26-27, lot 95651M201 list 6C26-22, lots 95651M200, 95651M202

Product code JLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)