—#175793

Product

Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

FDA product code: KNK — Acid, Uric, Uricase (Colorimetric)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K062862
Affected lot / code info: All lots

Why it was recalled

NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued letters dated 8/21/2018 via email or postal mail if an email address was not available on 8/24/2018 to their customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-223-0139 in the United States and Canada. Outside the United States and Canada contact local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

Timeline

Recall initiated: 2018-08-24
Terminated: 2024-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.