Z-0701-2013Class II

Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical...

Name: Z-0701-2013 Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical...
Creator: Becton Dickinson & Co.
Published: 2012-09-18
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-09-18 / Terminated / root cause: design

FDA source

Becton Dickinson & Co. began a recall of Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument on 2012-09-18. FDA classified it as Class II and gives the reason as "Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0701-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Posted: 2013-01-22
Terminated: 2013-02-04
Recalling firm: Becton Dickinson & Co
Product: Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Reason for recall: Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 86 Instruments
Distribution: USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0701-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0701-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-22

Product code NJR

K111860Class IBd Max Gbs Assay, Bd Max InstrumentBecton, Dickinson & CO / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)