CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report

Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol recalled

Beckman Coulter is recalling Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is, distributed nationwide in the US. The recall was initiated on 13 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled43,877 units total (10,496 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1933-2016
FDA event ID: 73921
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2016
FDA classified: 8 Jun 2016
Reported: 15 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

13 Apr 2016	Recall initiated by company
8 Jun 2016	Classified by FDA	+56 days
15 Jun 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 73921

This product is part of a recall event; the main page for the event is Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 recalled.

Reported	Class	Recall	Company	Reason	Where
15 Jun 2016	CLASS II	Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 recalled	Beckman Coulter	Potency & Assay	Nationwide
15 Jun 2016	CLASS II	Lipase, Catalog No. OSR6x30 Product Usage recalled by Beckman Coulter	Beckman Coulter	Potency & Assay	Nationwide
15 Jun 2016	CLASS II	Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride recalled	Beckman Coulter	Potency & Assay	Nationwide
15 Jun 2016	CLASS II	Uric Acid recalled by Beckman Coulter	Beckman Coulter	Potency & Assay	Nationwide

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