FDA Device recall Z-0312-2019
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX Syste…
- FDA Device
- Class II
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class II recall of BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX Syste… by Becton Dickinson And, citing A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vagin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0312-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-24 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Reason
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
Identifiers
| code_info | Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 7…Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0312-2019%22
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