HemoCue¿ Glucose 201 Microcuvettes — Class II medical device recall Z-2190-2013
Terminated recall by HemoCue AB, reported 2013-09-18, distributed nationwide. During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
| Recall number | Z-2190-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HemoCue AB, Angelholm, N/A, Sweden |
| Recall initiated | 2013-07-15 |
| Classified | 2013-09-11 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, DE, DK, EG, ES, FI, FR, GB, GR, IE, IT, KE, NL, NO, NZ, OM, PL, QA, SE, VN |
| Lot numbers | 1207767, 1208500, 1208501, 1208502, 1208503, 1208772, 1208773, 1208775, 1208777-1208781, 1208782-1208784, 1208785, 1208786, 1208787, 1208788, 1208789, 1208790, 1208792, 1208793, 1208794, 1208795, 1208796, 1208797, 1208798, 1208799, 1209504, 1209510, 1209511, 1209512, 1209513-1209517, 1209518-1209521, 1209522, 1209523, 1209527-1209531, 1209532, 1209533, 1209534, 1209535, 1209536, 1209537, 1209538 and 139 more |
| Model numbers | 110705, 110717, 110718, 110721 |
Product
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
Reason for recall
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
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-2190-2013. 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.