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Terminated

MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

FDA Recall Z-0053-05 · Posted 2004-10-28

Recalling FirmbioMerieux
Recall StatusTerminated
Product CodeGJA
Date Initiated2004-08-20
Date Terminated2005-06-09
Product Quantity1165 units

Reason for Recall

Complaints were received from the field regarding prolonged clot times, high control values and erratic results.

Firm Action

Consignees were notified by letter on 8/20/2004.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K802117FIBRI QUIKGeneral Diagnostics · 1980-09-26

Official Source

View FDA Recall →

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

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