COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 recall
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
Why was COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 recalled?
.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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Not applicable
- Product
- COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 4976
- Distribution
- Nationwide.
- Recall date
- November 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)