Roche Tina-Quant Hemoglobin A1c Test Recalled for Erroneously High Results
Roche Diagnostics is recalling Tina-Quant Hemoglobin A1c Gen. 2 tests because they may produce erroneously high results, potentially leading to incorrect diabetes treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk of harm (hypoglycemia due to incorrect treatment) where specific injury reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 4,976 units of the Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test, catalog numbers 04528123190 and 05401640190. The recall covers single cassettes and bottles of reagents distributed nationwide. The issue affects multiple lots and involves elevated quality control and patient sample recovery.
The defect can lead to erroneously high Hemoglobin A1c (HbA1c) results. For patients with known diabetes, these inaccurate results might lead to therapeutic consequences, such as the introduction of another oral antidiabetic medication or insulin, or an increase in dosage. This can further lead to an increased risk of hypoglycemia. Because the issue is difficult to detect, a relevant medical risk for the patient cannot be entirely excluded.
Healthcare providers and laboratories should stop using the affected cassettes and bottles and contact Roche Diagnostics for instructions on returning the product.
The recalled product
- Product
- Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
- 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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