Medical device recalls Moderate risk

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

Recall date
April 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2656-2017
FDA classification
Class II
Brand / firm
JAS Diagnostics Inc.
Sold / distributed
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

Why it was recalled

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

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

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