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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
All lot numbers containing the numbers 918301, exp. 2011-01.
Products Sold
All lot numbers containing the numbers 918301; exp. 2011-01.
Pointe Scientific, Inc. is recalling Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU7 due to A process deviation occurred during the production of the R1 component which may affect its performance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A process deviation occurred during the production of the R1 component which may affect its performance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026