Recall Z-2328-2019— Becton Dickinson & Co.

Name: FDA recall Z-2328-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-17

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2019-07-17, terminated 2020-05-13. It names one FDA 510(k) clearance: K120138. Product: Kit BD Max MRSA; Catalog # 442953. Reason: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2019-07-17
Terminated: 2020-05-13
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K120138 — BD MAX MRSA ASSAY, BD MAX INSTRUMENTBd Diagnostics (Geneohm Sciences Canada, Inc)·cleared 2012-07-05

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

Kit BD Max MRSA; Catalog # 442953

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

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