Z-1576-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- March 10, 2016
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,691
Product Description
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Reason for Recall
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
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.
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.