Date Initiated by Firm | August 24, 2018 |
Create Date | October 24, 2019 |
Recall Status1 |
Terminated 3 on August 02, 2024 |
Recall Number | Z-0210-2020 |
Recall Event ID |
83583 |
Product Classification |
Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
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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
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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 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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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