Z-3128-2011

Inhibin A ELISA, Part Number: DSL-10-28100-4

Name: Z-3128-2011 Inhibin A ELISA, Part Number: DSL-10-28100-4
Creator: Beckman Coulter Inc.
Published: 2010-11-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-11-10 / Terminated / root cause: sterility

FDA source

Beckman Coulter Inc. began a recall of Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human... on 2010-11-10. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-3128-2011
Status: Terminated
Initiated: 2010-11-10
Posted: 2011-09-02
Terminated: 2012-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Product code: NDR Enzyme Immunoassay, Inhibin-A
Reason for recall: The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761.
Root cause tag: sterility
FDA root cause: Other
Action: Beckman Coulter initiated an "URGENT PRODUCT CORRECTION" on June 15, 2011, via a telephone script to the only one customer impacted by the recalled product. The telephone script provided an explanation of the problem identified and the actions to be taken. Beckman Coulter recommended that the customer discontinue use of the recalled product as a preventative measure. Beckman will send a representative to the customer's facility to replace the recalled product in all remaining kits of the affected lot. The customer was instructed to share this information with laboratory staff. For any questions concerning this information, contact Beckman Coulter at 952-368-7874.
Quantity in commerce: 342 units
Distribution: (USA) Nationwide Distribution in the state of CA
Product codes and lots: Lot # 110761

Product code NDR

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)