Recall Z-1662-2013— Becton Dickinson & Co.

Name: FDA recall Z-1662-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-31

Class III · Terminated

Class III FDA medical device recall by Becton Dickinson & Co., initiated 2013-05-31, terminated 2013-08-19. It names one FDA 510(k) clearance: K111860. 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class III
Status: Terminated
Initiated: 2013-05-31
Terminated: 2013-08-19
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.