FDA Device recall Z-2307-2019
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056 by Becton Dickinson And, citing false elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2307-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-12 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Reason
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Identifiers
| code_info | UDI: (01)30382903680567 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2307-2019%22
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