Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling 29 units of BD MAX CT/GC/TV Verification and Control Panel (Catalog Number 8193, Lot Numbers 8193-04 and 8193-06) due to real-time shelf life testing that failed at 24 months. The affected product contains high, medium, and low level controls and was distributed worldwide, including to locations across the United States (Alaska, California, DC, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia) as well as Australia, Belgium, Canada, India, and the United Kingdom.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Real-time shelf life testing failed at 24 months
Reason for recall: Real-time shelf life testing failed at 24 months Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom. Quantity: 29 units Lot/code info: Catalog Number: 8193; Lot Number: 8193-04, 8193-06; UDI: 70845357041080
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.