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Class 2 Device Recall Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. |
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Date Initiated by Firm |
August 24, 2018 |
Create Date |
October 24, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0211-2020 |
Recall Event ID |
83583 |
510(K)Number |
K062862
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Product Classification |
Acid, uric, uricase (colorimetric) - Product Code KNK
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Product |
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact |
800-223-0130
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Manufacturer 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.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
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. |
Quantity in Commerce |
19,834 uits |
Distribution |
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KNK and Original Applicant = OLYMPUS AMERICA, INC.
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