Jas Diagnostics/Drew Scientific recalls Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysi…

Recall date

March 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1576-2016

FDA classification

Class II

Brand / firm

Jas Diagnostics/Drew Scientific

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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