Class II — Jas Diagnostics/Drew Scientific
| Recalling firm | JAS Diagnostics/Drew Scientific |
|---|---|
| Registered facility | JAS Diagnostics/Drew Scientific (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check. |
| Product | Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL. |
| 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. |
| Initiated | 2016-03-10 |
| Classified | 2016-04-27 |
| Terminated | 2019-08-21 |
| Recall number | Z-1576-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Jas Diagnostics/Drew Scientific (Z-1576-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73650/
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