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Recall Observatory FDA recall evidence

Device product

Phoenix AST-s Indicator, Catalog Number 246009

Z-0933-2019

December 20, 2018

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 81952
Status
Terminated
Classification
Class II
Quantity
62880 total
Official record key
device-enforcement:Z-0933-2019

Official wording

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

Code information: Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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