FDA Device recall Z-0984-2022
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control
- FDA Device
- Class III
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class III recall of Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control by Beckman Coulter, citing IRISpec CA failures for glucose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0984-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-02-16 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
Reason
IRISpec CA failures for glucose.
Identifiers
| code_info | Lot #583-21 and higher, UDI 10837461002611. |
|---|
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-0984-2022%22
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