Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
This recall has been terminated (originally issued March 5, 2010).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- July 29, 2009
- Posted
- March 5, 2010
- Terminated
- December 6, 2010
- Recall Number
- Z-1014-2010
- Quantity
- 2
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
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.
Distribution
California.
Lot / Code Info
Lot 817103-337.
Root 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.
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