FDA Device recall Z-0933-2022
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog…
- FDA Device
- Class II
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog… by Medline Industries Northfield, citing the product was stored incorrectly due to improper storage controls which may lead to delayed results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0933-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-08 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | AL, FL, NE, OH, TX, WA, WI |
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
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Identifiers
| code_info | Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023. |
|---|
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-0933-2022%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.