Reported May 4, 2016 · Terminated

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

Jas Diagnostics/Drew Scientific

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/Drew Scientific · 14100 NW 57th Ct · Miami Lakes, FL · 33014-3107

Is this the product you have?

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

8 of 8 products

Products covered by this recall
#Product as published
1Lot # 0825, exp 01/06/2018
2Lot # 0826, exp 01/06/2018
3Lot # 0827, exp 01/06/2018
4Lot # 0828, exp 01/21/2018
5Lot # 0829, exp 01/21/2018
6Lot # 0830, exp 01/21/2018
7Lot # 0831, exp 01/21/2018
8and Lot # 0832, exp 01/21/2018.
Amount recalled
7,691

Where it was sold

Why it was recalled

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

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 Aug 21, 2019 · Data as of Sep 19, 5:19 PM UTC

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