Recall Z-0912-2010
Pointe Scientific, Inc. · initiated December 1, 2009
Product
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.
Codes / lots: All lot numbers containing the numbers 918301; exp. 2011-01.
Reason for recall
A process deviation occurred during the production of the R1 component which may affect its performance.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0912-2010
- Initiated
- December 1, 2009
- Posted by FDA
- March 2, 2010
- Terminated
- October 8, 2010
- Product code
- KNK – Acid, Uric, Uricase (Colorimetric)
- Quantity
- 12 kits
- Distribution
- Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0913-2010 | Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton…A process deviation occurred during the production of the R1 component which may affect its performance. | 12/01/2009Terminated |