Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Check against the official notice below — it lists the full affected range.
DiaSorin Molecular LLC is recalling the Simplexa Direct Amplification Disc Kit (Product Kit Code MOL1455) because a subset of affected discs may leak when used more than once with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well containing a positive sample could cause cross-contamination in laboratory areas if not properly cleaned. The recall affects approximately 29,495 kits distributed across numerous U.S. states and several countries worldwide, including Canada, Australia, Israel, and others.
The affected kits are identified by specific lot numbers, with Kit Lot numbers ranging from 12410N through 13652N (most of which were distributed in the U.S., except Kit Lot #13242N which was shipped to Europe). The record does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Reason for recall: A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned. Distribution: US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United Arab Emirates. Quantity: 29495 kits Lot/code info: Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers): 12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*. *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.