FDA Device recall Z-2202-2021
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent
- FDA Device
- Class III
- terminated
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class III recall of Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent by Stanbio Laboratory, citing deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2202-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-07-12 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stanbio Laboratory |
| Distribution | US |
Product
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Reason
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Identifiers
| code_info | Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380…Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2202-2021%22
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