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Recall Observatory FDA recall evidence

Device product

Phoenix AST Indicator, Catalog Number 246004

Z-0934-2019

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-0934-2019

Official wording

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

Code information: Batch Numbers 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525

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.