FDA Device recall Z-1662-2013
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents…
- FDA Device
- Class III
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class III recall of BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents… by Becton Dickinson And, citing electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1662-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-31 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Identifiers
| code_info | Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272 |
|---|
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-1662-2013%22
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