Reported Jul 12, 2017 · Terminated

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

JAS Diagnostics Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: JAS Diagnostics Inc. · 14100 NW 57th Ct · Miami Lakes, FL · 33014-3107

Is this the product you have?

  • Drew Scientific
  • DREW 3-PAC Reagent Kit containing
    • 5L Diluent
    • 750 mL Enzymatic Cleaner
    • and 125 mL Lysing Reagent
Lot codes and dates
    • 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
Amount recalled
14,064

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 6, 2020 · Data as of Sep 19, 6:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.