Device product
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Z-2656-2017
Product summary
- Event
- Event 77464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,064
- Official record key
device-enforcement:Z-2656-2017
Official wording
Reason: May result in elevated platelet backgrounds during routine startup/background checks.
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
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
Derived failure modes
-
Unknown
May result in elevated platelet backgrounds during routine startup/background checks.