Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent — Class II medical device recall Z-2656-2017
Terminated recall by JAS Diagnostics Inc., reported 2017-07-12, distributed in AL, AR, CA, FL, GA, IA, IN, LA…. May result in elevated platelet backgrounds during routine startup/background checks.
| Recall number | Z-2656-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | JAS Diagnostics Inc., Miami Lakes, FL, United States |
| Recall initiated | 2017-04-21 |
| Classified | 2017-06-30 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2020-01-06 |
| Distributed | AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, PR, SC, TN, TX |
| Countries outside the US | AE, BO, CO, CR, EC, EG, ID, IQ, IT, KR, MX, PH, RU, SI, TN, VE, VN |
| Quantity | 14,064 |
| Lot numbers | 0868, 0869, 0870, 0871, 0872, 0873, 0874, 0875, 0876, 0877, 0879, 0880, 0881, 0882 |
| Expiration dates | 2018-11-28, 2019-01-10, 2019-02-06, 2019-02-23 |
Product
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Reason for recall
May result in elevated platelet backgrounds during routine startup/background checks.
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-2656-2017. 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.