Jas Diagnostics/Drew Scientific: Medical Device Recall in 2016 - (Recall #: Z-1576-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

Product Classification:

Class II

Date Initiated: March 10, 2016

Date Posted: May 4, 2016

Recall Number: Z-1576-2016

Event ID: 73650

Reason for Recall:

The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.

Status: Terminated

Product Quantity: 7,691

Code Information:

Lot # 0825, exp 01/06/2018; Lot # 0826, exp 01/06/2018; Lot # 0827, exp 01/06/2018; Lot # 0828, exp 01/21/2018; Lot # 0829, exp 01/21/2018; Lot # 0830, exp 01/21/2018; Lot # 0831, exp 01/21/2018; and Lot # 0832, exp 01/21/2018.

Distribution Pattern:

Worldwide Distribution - US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX. and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated