Recall Z-1014-2010
Pointe Scientific, Inc. · initiated July 29, 2009
Product
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
Codes / lots: Lot 817103-337.
Reason for recall
R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
FDA-determined cause: Error in labeling
Action taken
Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.
Details
- Recall number
- Z-1014-2010
- Initiated
- July 29, 2009
- Posted by FDA
- March 5, 2010
- Terminated
- December 6, 2010
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- Quantity
- 2
- Distribution
- California.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI