Terminated

Phoenix AST Indicator, Catalog Number 246004

FDA Recall Z-0934-2019 · Posted None

Recalling FirmBecton Dickinson & Co.

Recall StatusTerminated

Product CodeLON

Date Initiated2018-12-20

Date Terminated2020-04-10

Product Quantity62880 total

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050745BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/MLBecton, Dickinson & CO · 2005-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.