Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
This recall has been terminated (originally issued December 10, 2010).
- Recall Initiated
- March 10, 2010
- Posted
- December 10, 2010
- Terminated
- August 4, 2011
- Recall Number
- Z-0588-2011
- Quantity
- 21171
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.
Distribution
Nationwide Distribution throughout the US.
Lot / Code Info
Lot Number: DE0320, FC0306, GB0342, EA0334, FB0278, DA0293, GB0286, FA0355, EA0362, EB0362.
Root Cause
Other
Action Taken
Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.
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