Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16

FDA device recall Z-1025-2015 · posted 2015-01-28 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CHH

Quantity affected

59,965 units total (21,782 units in US)

Distribution

Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China

Date initiated

2014-12-15

Date posted

2015-01-28

Date terminated

2016-02-19

Location

Brea, CA

Related 510(k) clearances