FDA Device

Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

Hazard

May result in elevated platelet backgrounds during routine startup/background checks.

What You Should Do

Remedy

The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.

Products

Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Brand
JAS Diagnostics Inc.
UPC
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

Units Affected

14,064