FDA Recall
Terminated
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Recall: Z-2399-2008
·
Initiated July 18, 2008
Recall
- Recall Number
- Z-2399-2008
- Event Number
- 49044
- Firm
- DiaDexus, Inc
- FEI Number
- 3003643666
- Product Code
- NOE
- Status
- Terminated
- Root Cause
- Finished device change control
- Initiated
- July 18, 2008
- Posted
- September 26, 2008
- Terminated
- December 22, 2009
- Address
- 343 Oyster Point Blvd, South San Francisco, CA, 94080-1913
Description
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Reason
Product may give Lp-PLA2 values at up to 22% lower than accurate values.
Action
All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.
Distribution
US, OUS: UK and Germany.
Quantity
65 (total)