STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
This recall has been terminated (originally issued January 20, 2006).
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- October 26, 2005
- Posted
- January 20, 2006
- Terminated
- March 1, 2006
- Recall Number
- Z-0408-06
- Quantity
- 150 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
Distribution
Product was distributed to 23 direct account customers nationwide.
Lot / Code Info
Lot 0422671 exp. March 2006.
Root Cause
Other
Action Taken
Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.
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