Recall Z-1423-2013— Becton Dickinson & Co.

Name: FDA recall Z-1423-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-12

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-04-12, terminated 2013-09-28. It names one FDA 510(k) clearance: K896398. Product: BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.. Reason: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Terminated: 2013-09-28
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K896398 — DIFCO OXIDASE DRYSLIDEDifco Laboratories, Inc.·cleared 1989-12-18

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

BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.

Reason for recall

In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

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