Z-2656-2017Class II

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

Name: Z-2656-2017 Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing...
Creator: JAS Diagnostics Inc.
Published: 2017-04-21
License: https://open.fda.gov/license/

JAS Diagnostics/Drew Scientific / initiated 2017-04-21 / Terminated / root cause: manufacturing process

FDA source

JAS Diagnostics Inc. began a recall of Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent on 2017-04-21. FDA classified it as Class II and gives the reason as "May result in elevated platelet backgrounds during routine startup/background checks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2656-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-21
Posted: 2017-06-30
Terminated: 2020-01-06
Recalling firm: JAS Diagnostics/Drew Scientific
Product: Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Product code: GKZ Counter, Differential Cell
Reason for recall: May result in elevated platelet backgrounds during routine startup/background checks.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.
Quantity in commerce: 14,064
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2656-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2656-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-06-30

Product code GKZ

K071562Class IID3 Hematology Analyzer, Model D3Drew Scientific, Inc. / cleared 2007-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)