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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix ASTs Indicator

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 Class 2 Device Recall Phoenix ASTs Indicatorsee related information
Date Initiated by FirmDecember 20, 2018
Create DateFebruary 23, 2019
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-0933-2019
Recall Event ID 81952
510(K)NumberK050745 
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
ProductPhoenix AST-s Indicator, Catalog Number 246009
Code Information Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813 
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
Manufacturer Reason
for Recall		Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent 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.
Quantity in Commerce62880 total
DistributionThe 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LON
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