Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack recall
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Why was Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack recalled?
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
- Recalling firm
- Jas Diagnostics/Drew Scientific
- Quantity
- 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.
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)