Z-0934-2019Class II

Phoenix AST Indicator, Catalog Number 246004

Name: Z-0934-2019 Phoenix AST Indicator, Catalog Number 246004
Creator: Becton Dickinson & Co.
Published: 2018-12-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-12-20 / Terminated

FDA source

Becton Dickinson & Co. began a recall of Phoenix AST Indicator, Catalog Number 246004 on 2018-12-20. FDA classified it as Class II and gives the reason as "Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0934-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Posted: 2019-02-23
Terminated: 2020-04-10
Recalling firm: Becton Dickinson & Co
Product: Phoenix AST Indicator, Catalog Number 246004
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Product Advisory letters dated 12/20/18 were sent to customers. Amended Urgent Medical Device Product Advisory letters dated 1/23/19 were also sent to customers.
Quantity in commerce: 62880 total
Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam
Product codes and lots: Batch Numbers 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-23
Z-0934-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-23
Z-0935-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-23

Product code LON

K050745Class IIBd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/mlBecton, Dickinson & CO / cleared 2005-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)