—#37971

Product

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

FDA product code: GJS — Test, Time, Prothrombin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K974566
Affected lot / code info: Product numbers 259846, 259847, Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005) to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: BIOMERIEUX, INC.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand

Timeline

Recall initiated: 2005-03-07
Posted by FDA: 2005-05-18
Terminated: 2006-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.