Recall Z-1202-2009 ยท CIG Diazo Colorimetry, Bilirubin
Pointe Scientific, Inc.
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
| Date | Apr 17, 2009 (initiated Feb 2, 2009) |
| Status | Terminated |
| Reason | The product performance fails due to precipitation of the R2 component. |
| Root cause | Process control |
| Action | Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300. |
| Quantity | 24 kits |
| Distribution | Worldwide Distribution -- USA, Chile and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040391 | TOTAL BILIRUBIN REAGENT SET Pointe Scientific, Inc.,, Jun 2, 2004 |