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U.S. Department of Health and Human Services

Class 2 Device Recall Drew Scientific Inc. D3 Hematology AnalyzerD3 Reagent Pack

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 Class 2 Device Recall Drew Scientific Inc. D3 Hematology AnalyzerD3 Reagent Packsee related information
Date Initiated by FirmMarch 10, 2016
Create DateApril 27, 2016
Recall Status1 Terminated 3 on August 21, 2019
Recall NumberZ-1576-2016
Recall Event ID 73650
510(K)NumberK071562 
Product Classification Counter, differential cell - Product Code GKZ
ProductDrew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
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.
FEI Number 3003071743
Recalling Firm/
Manufacturer		 Jas Diagnostics/Drew Scientific
14100 NW 57th Ct
Miami Lakes FL 33014-3107
For Additional Information ContactTracy T. Chadwrick
305-748-2780
Manufacturer Reason
for Recall		The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
FDA Determined
Cause 2		Process control
ActionJAS 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 Commerce7,691
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GKZ
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