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Access Inhibin A

Beckman Coulter, Inc. · Model A36097 · UDI-DI 15099590203047

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Access Inhibin A assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of dimeric inhibin A in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems.

Recalls

Date	Firm	Reason
2010-12-21	Beckman Coulter Inc.	The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.
2010-12-21	Beckman Coulter Inc.	The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.
2010-11-10	Beckman Coulter Inc.	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.