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Recall Observatory FDA recall evidence

Device product

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

Z-1576-2016

March 10, 2016

Class II

Product summary

Firm
Jas Diagnostics/Drew Scientific
Event
Event 73650
Status
Terminated
Classification
Class II
Quantity
7,691
Official record key
device-enforcement:Z-1576-2016

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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