HemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging
HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves packaging integrity (punctured pouches) which could affect test accuracy but does not involve a direct physical injury mechanism like fire or choking, nor are there reports of illness or injury.
Plain-English summary
HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes, which are used with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer for the quantitative determination of glucose in whole blood. The recall was initiated after the company discovered punctured single-pack pouches during a complaint investigation.
The affected products include 22,215 boxes of 100 cuvettes distributed in the US and 34,841 distributed outside the US. The recall covers specific model numbers 110705, 110717, 110718, and 110721, along with a wide range of lot numbers listed in the official recall notice. Distribution was worldwide, including the United States and numerous international markets.
Consumers and healthcare providers should stop using the affected microcuvettes and contact HemoCue AB for further instructions or a replacement. The punctured packaging may compromise the integrity of the microcuvettes, potentially affecting the accuracy of glucose measurements.
The recalled product
- 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
- Manufacturer
- HemoCue AB
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model #
- 110705
- Lot #
- 1207767
- 1208500
- 1208501
- 1208772
- 1208773
- 1208775
- 1208777-1208781
- 1208787
- 1208788
- 1208794
- 1208795
- 1209513-1209517
- 1209527-1209531
- 1209539
- 1209540
- 1209546
- 1209547
Distribution
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