Glucose Hexokinase — Class II medical device recall Z-0827-2015
Terminated recall by JAS Diagnostics Inc., reported 2014-12-24, distributed in CA, FL, GA, MN, NC, NV, NY, OR…. Product is not performing according to specifications. Control 2 does not consistently recover within its assi
| Recall number | Z-0827-2015 |
|---|---|
| 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 | 2014-10-23 |
| Classified | 2014-12-17 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-02-26 |
| Distributed | CA, FL, GA, MN, NC, NV, NY, OR, PR, TN, TX |
| Countries outside the US | FR, GH, HT, JM, KY, TT |
| Quantity | 390 |
| Lot numbers | N0702011K, N0702012, N0702013K, P010201K, P010202K, P010203K, P010204K, P010205K, P010206K, P0402015K, P0402016K, P0502010K, P0502011K, P0502012K, P0502013K, P0502014K, P050207K, P050208K, P050209K, P0802017K |
| Expiration dates | 2014-10, 2015-04, 2015-07, 2015-08, 2015-11 |
Product
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Reason for recall
Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
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-0827-2015. 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.