Becton, Dickinson and Company, BD MAX (tm) (6 channel)… recallZ-0701-2013 · Becton Dickinson & Co. · initiated Sep 18, 2012
Class II Terminated All recalls posted in January 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
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
FDA root cause category: Device Design
What the company is doing
Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.
Recall details
- Recall number
- Z-0701-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 18, 2012
- Posted by the FDA
- Jan 22, 2013
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 86 Instruments
- Product code
- NJR
- FDA submissions
- K111860
- Distribution
- USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
Product description
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Code information (models, lots, serial numbers)
Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page