Radiometer HemoCue Glucose 201 Microcuvettes Recalled for Discoloration and Inaccurate Results
Radiometer America Inc. is recalling HemoCue Glucose 201 Microcuvettes because they show discoloration and provide results outside specification near the end of their shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results for a critical health metric (glucose), which poses a risk of harm if used for treatment decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Radiometer America Inc. is recalling approximately 3,712,900 HemoCue Glucose 201 Microcuvettes. The affected microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. The recall covers specific lots identified by model numbers 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720, as well as subsequent lots 1310227, 1310252, and 1310257.
The recall was initiated because batches of the microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approximately after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 to display a plasma equivalent glucose result. The microcuvettes are intended for In Vitro Diagnostic use.
The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Canada, Austria, Australia, and Germany. Consumers and healthcare providers should stop using the affected microcuvettes and contact Radiometer America Inc. for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- Radiometer America Inc
- Affected units
- 3,712,900
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 Number 110705: Lot numbers: 1310500
- 1310501
- 1310502
- 1310503
- 1310518
- 1310519
- 1310520
- 1310521
- 1310767
- 1310768
- 1310769
- 1310770
- 1310771
- 1310772
- 1310779
- 1310780
- 1310781
- 1310788
- 1310789
- 1310790
Distribution
Distributed nationwide across the United States.
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