Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0396-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160

Product Classification:

Class II

Date Initiated: October 4, 2016

Date Posted: November 23, 2016

Recall Number: Z-0396-2017

Event ID: 75366

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.

Status: Terminated

Product Quantity: 4976

Code Information:

Not applicable

Distribution Pattern:

Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated