Z-1026-2015Class II

Beckman Coulter, Lactate Assay, Catalog No. OSR6X93

Name: Z-1026-2015 Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Creator: Beckman Coulter Inc.
Published: 2014-12-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-12-15 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 on 2014-12-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1026-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-15
Posted: 2015-01-28
Terminated: 2016-02-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Product code: KHP Acid, Lactic, Enzymatic Method
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 31,799 units total (15,841 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, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1026-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1023-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28
Z-1024-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28
Z-1025-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28
Z-1026-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28

Product code KHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)