Recall Z-1934-2016— Beckman Coulter Inc.

Name: FDA recall Z-1934-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-13

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2016-04-13, terminated 2016-06-30. It names one FDA 510(k) clearance: K063804. Product: Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.. Reason: Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-13
Terminated: 2016-06-30
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.·cleared 2007-03-23

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

Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.

Reason for recall

Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

Data sourced from openFDA. This site is unofficial and independent of the FDA.