—#170400

Product

Phoenix AST Indicator, Catalog Number 246004

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K050745
Affected lot / code info: Batch Numbers 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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

Timeline

Recall initiated: 2018-12-20
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.