BD MAX Instrument — Class III medical device recall Z-1662-2013
Terminated recall by Becton Dickinson & Co., reported 2013-07-10, distributed nationwide. Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as
| Recall number | Z-1662-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2013-05-31 |
| Classified | 2013-07-03 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2013-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, CN, HK, JP, SG |
| Quantity | 71 instruments |
| Reason classes | labeling |
| Serial numbers | CT0173, CT0249, CT0253, CT0260, CT0262, CT0263, CT0265, CT0269, CT0272 |
| Model numbers | 441916 |
Product
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Reason for recall
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
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-1662-2013. 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.