FDA Device recall Z-0777-2023
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only by Beckman Coulter, citing beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0777-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-18 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Reason
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
Identifiers
| code_info | UDI/DI 10837461002611, Lot 565-21: 11-30-2022 |
|---|
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-0777-2023%22
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