FDAFDA · Food and drugs·Recall number Z-2656-2017
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Published July 12, 2017 · Recall initiated: April 21, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
May result in elevated platelet backgrounds during routine startup/background checks.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- JAS Diagnostics Inc.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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