FDA-Device2016-11-23Class II
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
Roche Diagnostics Operations, Inc.
Hazard
.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.
Sold states
Nationwide.
Affected count
4976
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0396-2017Don't want to check this manually?
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