Z-0210-2020Class II

Beckman Coulter Lipase, REF OSR6130 and OSR6230

Name: Z-0210-2020 Beckman Coulter Lipase, REF OSR6130 and OSR6230
Creator: Beckman Coulter Inc.
Published: 2018-08-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-08-24 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter Lipase, REF OSR6130 and OSR6230 on 2018-08-24. FDA classified it as Class II and gives the reason as "NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0210-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Posted: 2019-10-24
Terminated: 2024-08-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Product code: CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Reason for recall: NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters dated 8/21/2018 via email or postal mail if an email address was not available on 8/24/2018 to their customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-223-0139 in the United States and Canada. Outside the United States and Canada contact local Beckman Coulter Representative.
Quantity in commerce: 20,926 units
Distribution: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0210-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24
Z-0211-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24

Product code CDT

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)