Z-0396-2017 Class II Terminated
FDA device recall Z-0396-2017 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
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
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.
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-0396-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026