HemoCue¿ Glucose 201 Microcuvettes — Class II medical device recall Z-0873-2015
Terminated recall by Radiometer America Inc, reported 2014-12-31, distributed nationwide. Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification
| Recall number | Z-0873-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-12-24 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CY, CZ, DE, DK, FI, FR, GB, HK, HR, HU, IE, IN, IS, JP, KE, MT, NL, NO, NP, NZ, PL, RO, RU, SE, SI, ZA |
| Quantity | 3,712,900 microcuvettes |
| Lot numbers | 1310202, 1310203, 1310204, 1310205, 1310206, 1310207, 1310208, 1310209, 1310210, 1310211, 1310212, 1310213, 1310214, 1310215, 1310216, 1310217, 1310218, 1310219, 1310221, 1310222, 1310223, 1310224, 1310225, 1310226, 1310227, 1310228, 1310229, 1310230, 1310231, 1310232, 1310234, 1310235, 1310236, 1310237, 1310238, 1310239, 1310240, 1310241, 1310242, 1310243 and 154 more |
| Model numbers | 110705, 110706, 110715, 110716, 110717, 110718, 110719, 110720 |
Product
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.
Reason for recall
Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag
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-0873-2015. 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.