Z-0395-2017 Class II Terminated
FDA device recall Z-0395-2017 was initiated by Roche Diagnostics Operations, Inc. on Oct 4, 2016 and is designated Class II. Reason for recall: Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred… The recall status is terminated (terminated Jun 5, 2017). Affected quantity: 4976.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2016
- Initiation Date
- Oct 4, 2016
- Termination Date
- Jun 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4976
Product Description
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
Reason for Recall
Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected, an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded.
Distribution Pattern
Nationwide.
Code Information
Not applicable
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0395-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026