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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Lipase, REF OSR6130 and OSR6230

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  Class 2 Device Recall Beckman Coulter Lipase, REF OSR6130 and OSR6230 see related information
Date Initiated by Firm August 24, 2018
Create Date October 24, 2019
Recall Status1 Open3, Classified
Recall Number Z-0210-2020
Recall Event ID 83583
Product Classification Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
Product Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Code Information All lots
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact
Manufacturer Reason
for Recall
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
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 20,926 units
Distribution Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
Total Product Life Cycle TPLC Device Report

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.