Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0395-2017)

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:

Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190

Product Classification:

Class II

Date Initiated: October 4, 2016

Date Posted: November 23, 2016

Recall Number: Z-0395-2017

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. 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.

Status: Terminated

Product Quantity: 4976

Code Information:

Not applicable

Distribution Pattern:

Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated