Recall Z-0933-2019— Becton Dickinson & Co.

Name: FDA recall Z-0933-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-20

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2018-12-20, terminated 2020-04-10. It names one FDA 510(k) clearance: K050745. Product: Phoenix AST-s Indicator, Catalog Number 246009. Reason: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Terminated: 2020-04-10
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K050745 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/MLBecton, Dickinson & CO·cleared 2005-04-29

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

Phoenix AST-s Indicator, Catalog Number 246009

Reason for recall

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

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