Roche Recalls Hemoglobin A1c Test Cassettes Due to High Results
Roche Diagnostics is recalling specific Hemoglobin A1c test cassettes because they may produce erroneously high results.
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 involves a medical device that produces inaccurate diagnostic results (erroneously high HbA1c), which poses a risk of harm through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 4,976 units of COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 test cassettes and bottles. The recall affects individual cassettes and bottles of reagents across multiple lots.
The recall was initiated because Roche confirmed elevated quality control and patient sample recovery for the affected items. This issue can lead to erroneously high Hemoglobin A1c (HbA1c) results.
The affected products were distributed nationwide. Healthcare facilities and laboratories should stop using the affected cassettes and bottles and contact Roche Diagnostics for instructions on how to return or dispose of the products.
The recalled product
- Product
- COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 4,976
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 (1)
- Not applicable
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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