Z-2082-2017Class II

HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL...

Name: Z-2082-2017 HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL...
Creator: Beckman Coulter Inc.
Published: 2017-04-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-04-03 / Terminated

FDA source

Beckman Coulter Inc. began a recall of HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction... on 2017-04-03. FDA classified it as Class II and gives the reason as "Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2082-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-03
Posted: 2017-05-12
Terminated: 2018-05-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
Product code: LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Reason for recall: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter dated 4/3/17 was sent to customers to inform them that Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole, Sulfasalazine, and Sulfapyridine. Customers are informed that with the administration of these drugs, the effects to patient analytes are: - Metamizole (Dipyrone) may generate false low Cholesterol, Enzymatic Creatinine, HDL Cholesterol, Lactate, Triglycerides and Uric Acid results. -Sulfasalazine may generate false high Salicylate results. -Sulfapyridine may generate false low Salicylate results. Customers are informed of the action and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center -Via http://www.beckmancoulter.com/customersupport/support -Via phone, call 1-800-854-3633 in the United States and Canada Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 91,996 units total (51,027 units in US)
Distribution: Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2082-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2078-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2079-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2080-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2081-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2082-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2083-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2084-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code LBS

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)