Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Tina-quant Complement C4 ver.2 Recalled by Roche Diagnostics Operations, Inc. Due to Roche has confirmed customer complaints of low quality...

Date: August 27, 2020
Company: Roche Diagnostics Operations, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Operations, Inc. directly.

Affected Products

Tina-quant Complement C4 ver.2, Catalog 05991994190

Quantity: 180 units

Why Was This Recalled?

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report