JAS Diagnostics Inc.: Medical Device Recall in 2017 - (Recall #: Z-2656-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 21, 2017

Date Posted: July 12, 2017

Recall Number: Z-2656-2017

Event ID: 77464

Reason for Recall:

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

Status: Terminated

Product Quantity: 14,064

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

Voluntary or Mandated:

Voluntary: Firm initiated