Recall Z-1014-2010 ยท CIG Diazo Colorimetry, Bilirubin
Pointe Scientific, Inc.
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
| Date | Mar 5, 2010 (initiated Jul 29, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 2 |
| Distribution | California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040391 | TOTAL BILIRUBIN REAGENT SET Pointe Scientific, Inc.,, Jun 2, 2004 |