Z-1933-2016Class II

Cholesterol, Catalog No. OSR6x16

Name: Z-1933-2016 Cholesterol, Catalog No. OSR6x16
Creator: Beckman Coulter Inc.
Published: 2016-04-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-04-13 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol... on 2016-04-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1933-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-13
Posted: 2016-06-08
Terminated: 2016-06-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
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.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated April 13, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the customer notification letter are instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support; (800) 223-0130 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 43,877 units total (10,496 units in US)
Distribution: Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, 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, Vietnam, 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-1933-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1930-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08
Z-1931-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08
Z-1932-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08
Z-1933-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08
Z-1934-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08

Product code CHH

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)