BD Max Instrument Reader Spare Part — Class II medical device recall Z-0312-2019
Terminated recall by Becton Dickinson & Co., reported 2018-11-07, distributed nationwide. A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Cand
| Recall number | Z-0312-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2018-09-24 |
| Classified | 2018-10-31 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, DK, ES, FR, IT, KW, OM, SA, SE, TR |
| Quantity | 23 |
| Serial numbers | 079577, 079896, 77048, 77062, 77108, 77373, 77543, 77707, 78154, 78182, 78321, 78352, 78363, 78387, 78481, 78503, 78584, 78615, 78665, 78667, 78711, 78832, 78840, 78856, 78857 and 8 more |
| Model numbers | 44336409, 8090369/443364 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0312-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.