Z-0494-03

Access Progesterone Assay, Part number 33550

Name: Z-0494-03 Access Progesterone Assay, Part number 33550
Creator: Beckman Coulter Inc
Published: 2002-12-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2002-12-06 / Terminated

FDA source

Beckman Coulter Inc began a recall of Access Progesterone Assay, Part number 33550 on 2002-12-06. The reason FDA records is "Primary tube sampling issue may cause false low results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0494-03
Status: Terminated
Initiated: 2002-12-06
Posted: 2003-01-30
Terminated: 2003-07-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Progesterone Assay, Part number 33550.
Product code: JLS Radioimmunoassay, Progesterone
Reason for recall: Primary tube sampling issue may cause false low results.
FDA root cause: Other
Action: Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.
Quantity in commerce: 6,655
Distribution: USA and Canada.
Product codes and lots: All Lots.

Product code JLS

K955769Class IAccess Progesterone AssayBio-Rad Laboratories, Inc. / cleared 1996-02-05

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)