Class II — HemoCue AB
| Recalling firm | HemoCue AB |
|---|---|
| Registered facility | HEMOCUE AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. |
| 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. |
| Quantity | 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. . |
| Initiated | 2013-07-15 |
| Classified | 2013-09-11 |
| Terminated | 2014-09-02 |
| Recall number | Z-2190-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — HemoCue AB (Z-2190-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65854/
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