PlainRecalls
FDA Devices Moderate Class II Terminated

Phoenix AST Indicator, Catalog Number 246004

Reported: March 6, 2019 Initiated: December 20, 2018 #Z-0934-2019

Product Description

Phoenix AST Indicator, Catalog Number 246004

Reason for Recall

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

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
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
Location
Sparks, MD

Frequently Asked Questions

What product was recalled?
Phoenix AST Indicator, Catalog Number 246004. Recalled by Becton Dickinson & Co.. Units affected: 62880 total.
Why was this product recalled?
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0934-2019.