FDA Device recall Z-0870-2014
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152 by Becton Dickinson And, citing improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0870-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-09 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
Reason
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Identifiers
| code_info | Catalog number 442296 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0870-2014%22
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