Z-2656-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- April 21, 2017
- Termination Date
- January 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,064
Product Description
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Reason for Recall
May result in elevated platelet backgrounds during routine startup/background checks.
Distribution Pattern
AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam
Code Information
Lot # 0868 Exp. Date 11/28/2018, Lot # 0869 & Lot 0870 Exp. Date 01/10/2019, Lot # 0871,0872, 0873, 0874 , 0875, and 0876 Exp. Date 02/06/2019, and Lot # 0877, 0877, 0879, 0880, 0881, and 0882 Exp. Date 02/23/2019