BD MAX Instrument, catalog #441916 recallZ-1662-2013 · Becton Dickinson & Co. · initiated May 31, 2013
Class III Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
FDA root cause category: Component change control
What the company is doing
Becton Dickinson (BD) notified their customers in the US by phone on May 31, 2013 and by an Urgent Field Correction Action letter dated May 2013. Customers were advised of the affected product, problem and actions to be taken. The letter informed customers that an onsite visit by a BD Service representative is planned to perform a system check so to determine if the instrument is affected. BD's field service team plans to immediately replace the module on site if the affected part is found. For questions contact BD Technical Services Department at 1-800-638-8663.
Recall details
- Recall number
- Z-1662-2013
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- May 31, 2013
- Posted by the FDA
- Jul 3, 2013
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 71 instruments
- Product code
- NJR
- FDA submissions
- K111860
- Distribution
- Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
Product description
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.
Code information (models, lots, serial numbers)
Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
Other devices under the same FDA submission
2 devices cleared under K111860 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD PCR Cartridge 437519Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall140 reports
- BD MAX™ GBS 441772Becton, Dickinson And Company · Nucleic acid amplification assay system, group b streptococcus, direct specimen test38 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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