Beta-Hydroxybutyrate Reagent A — Class III medical device recall Z-2200-2021
Terminated recall by Stanbio Laboratory, LP, reported 2021-08-11, distributed nationwide. Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quali
| Recall number | Z-2200-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanbio Laboratory, LP, Boerne, TX, United States |
| Recall initiated | 2021-07-12 |
| Classified | 2021-08-05 |
| Reported by FDA | 2021-08-11 |
| Terminated | 2022-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, DE, GB, HK, SG, TH, TW, VN |
| Quantity | 200 units |
| Reason classes | specification failure |
| Lot numbers | 158894 |
Product
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Reason for recall
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2200-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.