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Terminated

Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

FDA Recall Z-0913-2010 · Posted 2010-03-02

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeKNK
Date Initiated2009-12-01
Date Terminated2010-10-08
Product Quantity1 kit

Reason for Recall

A process deviation occurred during the production of the R1 component which may affect its performance.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970560URIC ACID (LIQUID) REAGENT SETPointe Scientific, Inc., · 1997-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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