FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Beckman Coulter Lipase, REF OSR6130 and OSR6230.
- Recall number
- Z-0210-2020
- Recalling firm
- Beckman Coulter Inc.
- Product
- Beckman Coulter Lipase, REF OSR6130 and OSR6230.
- Status
- Terminated
- Initiated
- 2018-08-24
- Posted
- not on file
- Terminated
- 2024-08-02
- Reason
- 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
- 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
- 20,926 units
- Distribution
- Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CDT
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28