STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- March 30, 2007
- Posted
- July 3, 2007
- Terminated
- November 30, 2009
- Recall Number
- Z-0979-2007
- Quantity
- 170 units
- Firm Location
- Parsippany, NJ
Reason for Recall
Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.
Distribution
Nationwide.
Lot / Code Info
Lot 061781, June 2008
Root Cause
Other
Action Taken
Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.
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