FDA Device recall Z-2199-2021
Beta-Hydroxybutyrate LiquiColor. 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 Beta-Hydroxybutyrate LiquiColor. 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-2199-2021 |
| 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
Beta-Hydroxybutyrate LiquiColor. 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: 2440-058/¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000519 Lot Numbers: 164312; 161081; 161039; 161031; 158972; |
|---|
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-2199-2021%22
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