FDA Device recall Z-0210-2020
Beckman Coulter Lipase, REF OSR6130 and OSR6230
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of Beckman Coulter Lipase, REF OSR6130 and OSR6230 by Beckman Coulter, citing NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0210-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-24 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Reason
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2020%22
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