FDA Device recall Z-0095-2023
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001 by Becton Dickinson And, citing the affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0095-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-15 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Reason
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Identifiers
| code_info | UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2023%22
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