FDA Device recall Z-0404-2022
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref
- FDA Device
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref by Medline Industries Northfield, citing affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0404-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-30 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Reason
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Identifiers
| code_info | Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148…Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All Medline Industries Northfield recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0404-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.