FDA Device recall Z-1606-2023
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL by Beckman Coulter, citing there is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1606-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-05 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Reason
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Identifiers
| code_info | All Lots: UDI-GI: 15099590020187 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1606-2023%22
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