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Recall Observatory FDA recall evidence

Device product

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

Z-2656-2017

April 21, 2017

Class II

Product summary

Firm
JAS Diagnostics Inc.
Event
Event 77464
Status
Terminated
Classification
Class II
Quantity
14,064
Official record key
device-enforcement:Z-2656-2017

Official wording

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

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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