Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards — Class II medical device recall Z-0933-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-04-20, distributed in AL, FL, NE, OH, TX, WA, WI. The product was stored incorrectly due to improper storage controls which may lead to delayed results.
| Recall number | Z-0933-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-03-08 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2023-02-27 |
| Distributed | AL, FL, NE, OH, TX, WA, WI |
| Quantity | 10 boxes |
| Lot numbers | 169141, 172093, 174703 |
| Model numbers | 2450-604, S-O2450604 |
| Expiration dates | 2023-04-30, 2023-06-30, 2023-08-31 |
Product
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
Reason for recall
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
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-0933-2022. 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.