STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the qua
FDA device recall Z-0408-06 · posted 2006-01-20 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GGP
- Quantity affected
- 150 units
- Distribution
- Product was distributed to 23 direct account customers nationwide.
- Date initiated
- 2005-10-26
- Date posted
- 2006-01-20
- Date terminated
- 2006-03-01
- Location
- Parsippany, NJ
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