Z-1576-2016Class II

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

Name: Z-1576-2016 Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL...
Creator: Jas Diagnostics/Drew Scientific
Published: 2016-03-10
License: https://open.fda.gov/license/

JAS Diagnostics/Drew Scientific / initiated 2016-03-10 / Terminated / root cause: manufacturing process

FDA source

Jas Diagnostics/Drew Scientific began a recall of Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL on 2016-03-10. FDA classified it as Class II and gives the reason as "The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check". 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-1576-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2016-04-27
Terminated: 2019-08-21
Recalling firm: JAS Diagnostics/Drew Scientific
Product: Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Product code: GKZ Counter, Differential Cell
Reason for recall: The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: JAS Diagnostics/ Drew Scientifics sent an Important Product Advisory letter dated March 10, 2016, to all affected customers. The domestic customers were notified via letter and international customers were notified via email. Customers were instructed to contact Drew Scientific Inc. Customer Service or Technical Service at 1-800-433-0945 for product replacement. The firm suggested a temporary workaround of performing five background runs three times per day in order to ensure background counts are running within specification.
Quantity in commerce: 7,691
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1576-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1576-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

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)