Recall Z-1023-2015— Beckman Coulter Inc.

Name: FDA recall Z-1023-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-15

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2014-12-15, terminated 2016-02-19. It names one FDA 510(k) clearance: K963424. Product: Beckman Coulter, Lipase Assay, Catalog No. OSR6X30. 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

510(k) clearances named in this recall

1 on FDA's record

K963424 — OLYMPUS LIPASE REAGENTOlympus America, Inc.·cleared 1997-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Beckman Coulter, Lipase Assay, Catalog No. OSR6X30

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.