Pointe Scientific, Inc. Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lot 817103-337.
Products Sold
Lot 817103-337.
Pointe Scientific, Inc. is recalling Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936 due to R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026