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Terminated

Chlamydia OIA. For in vitro diagnostic use,

FDA Recall Z-0615-03 · Posted 2003-03-06

Recalling FirmThermo Biostar, Incorporated
Recall StatusTerminated
Product CodeLJC
Date Initiated2003-02-07
Date Terminated2003-05-02
Product Quantity286 units

Reason for Recall

Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

Firm Action

All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.

Root Cause

Other

Distribution Pattern

Nationwide, and to France, New Zealand and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951010CHLAMYDIA OIABiostar, Inc. · 1995-10-07

Official Source

View FDA Recall →

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

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