Recall Z-0912-2010 ยท KNK Acid, Uric, Uricase (Colorimetric)
Pointe Scientific, Inc.
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
| Date | Mar 2, 2010 (initiated Dec 1, 2009) |
| Status | Terminated |
| Reason | A process deviation occurred during the production of the R1 component which may affect its performance. |
| Root cause | Device Design |
| Action | Pointe Scientific, Inc. issued an "Urgent: Medical Device Recall" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately. For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300. |
| Quantity | 12 kits |
| Distribution | Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970560 | URIC ACID (LIQUID) REAGENT SET Pointe Scientific, Inc.,, Mar 11, 1997 |