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Terminated

Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704

FDA Recall Z-0843-05 · Posted 2005-05-18

Recalling FirmBIOMERIEUX, INC.
Recall StatusTerminated
Product CodeGJS
Date Initiated2005-03-07
Date Terminated2006-10-16
Product Quantity19748 kits

Reason for Recall

The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.

Firm Action

Consignees were notified by letter on/about March 7, 2005.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974566MDA SIMPLASTIN HTFOrganon Teknika Corp. · 1998-02-24

Official Source

View FDA Recall →

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

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