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.
This recall has been terminated (originally issued March 2, 2010).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- December 1, 2009
- Posted
- March 2, 2010
- Terminated
- October 8, 2010
- Recall Number
- Z-0912-2010
- Quantity
- 12 kits
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
A process deviation occurred during the production of the R1 component which may affect its performance.
Distribution
Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.
Lot / Code Info
All lot numbers containing the numbers 918301; exp. 2011-01.
Root 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.