Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls — Class II medical device recall Z-0404-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2021-12-29, distributed nationwide. Affected product was shipped from the warehouse at room temperature instead of the required refrigerated envir
| Recall number | Z-0404-2022 |
|---|---|
| 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 | 2021-11-30 |
| Classified | 2021-12-21 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2023-01-06 |
| Distributed | Nationwide (US) |
| Quantity | 14 units |
| Lot numbers | 156205, 158144, 161603, 165148, 169124, 171961, 175250 |
| Serial numbers | 156205, 158144, 161603, 165148, 169124, 171961, 175250 |
| Model numbers | 2460-605, S-O2460605 |
Product
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Reason for recall
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
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-0404-2022. 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.