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

• Date Initiated by Firm: August 24, 2018
• Create Date: October 24, 2019
• Recall Status: Open, 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/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: 800-223-0130
• 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: 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.