Drew Scientific Inc — Class II medical device recall Z-1576-2016
Terminated recall by Jas Diagnostics/Drew Scientific, reported 2016-05-04, distributed in AL, AR, CA, FL, GA, IA, IN, KS…. The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
| Recall number | Z-1576-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jas Diagnostics/Drew Scientific, Miami Lakes, FL, United States |
| Recall initiated | 2016-03-10 |
| Classified | 2016-04-27 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2019-08-21 |
| Distributed | AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, TX |
| Countries outside the US | BO, EC, ES, IT, NL, PE, PK, SI, VE |
| Quantity | 7,691 |
| Lot numbers | 0825, 0826, 0827, 0828, 0829, 0830, 0831, 0832 |
| Expiration dates | 2018-01-06, 2018-01-21 |
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 for recall
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1576-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.