FDA Device recall Z-1576-2016
Drew Scientific Inc
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Drew Scientific Inc by Jas Diagnostics Drew Scientific, citing the reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1576-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-10 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Jas Diagnostics Drew Scientific |
| Distribution | AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, TX |
Product
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Reason
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
Identifiers
| code_info | 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 # 0…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1576-2016%22
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