Recall Z-0701-2013— Becton Dickinson & Co.

Name: FDA recall Z-0701-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-18

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2012-09-18, terminated 2013-02-04. It names one FDA 510(k) clearance: K111860. Product: Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.. Reason: Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Terminated: 2013-02-04
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

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

Reason for recall

Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

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