Z-1662-2013Class III

BD MAX Instrument, catalog #441916

Name: Z-1662-2013 BD MAX Instrument, catalog #441916
Creator: Becton Dickinson & Co.
Published: 2013-05-31
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-05-31 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of... on 2013-05-31. FDA classified it as Class III and gives the reason as "Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1662-2013
Classification: Class III
Status: Terminated
Initiated: 2013-05-31
Posted: 2013-07-03
Terminated: 2013-08-19
Recalling firm: Becton Dickinson & Co
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.
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Reason for recall: Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Root cause tag: labeling and UDI
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 71 instruments
Distribution: Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
Product codes and lots: Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1662-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1662-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-03

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)