Recall Z-1026-2015— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2014-12-15, terminated 2016-02-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Beckman Coulter, Lactate Assay, Catalog No. OSR6X93. Reason: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-15
- Terminated
- 2016-02-19
- Firm location
- Brea, CA, United States
Product description
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Reason for recall
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.