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Terminated

Access Progesterone Assay, Part number 33550.

FDA Recall Z-0494-03 · Posted 2003-01-30

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJLS
Date Initiated2002-12-06
Date Terminated2003-07-26
Product Quantity6,655

Reason for Recall

Primary tube sampling issue may cause false low results.

Firm 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.

Root Cause

Other

Distribution Pattern

USA and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955769ACCESS PROGESTERONE ASSAYBio-Rad Laboratories, Inc. · 1996-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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