Device product
Phoenix AST Indicator, Catalog Number 246004
Z-0934-2019
Product summary
- 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
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.