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Terminated

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

FDA Recall Z-0211-2020 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeKNK
Date Initiated2018-08-24
Date Terminated2024-08-02
Product Quantity19,834 uits

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc. · 2007-04-06

Official Source

View FDA Recall →

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

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