Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
This recall has been terminated (originally issued May 18, 2005).
- Company
- Biomerieux, Inc.
- Recall Initiated
- March 7, 2005
- Posted
- May 18, 2005
- Terminated
- October 16, 2006
- Recall Number
- Z-0843-05
- Quantity
- 19748 kits
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand
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.
Root Cause
Other
Action Taken
Consignees were notified by letter on/about March 7, 2005.
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