Skip to content
Recall Observatory FDA recall evidence

Device product

Tina-quant Complement C4 ver.2, Catalog 05991994190

Z-0103-2021

August 27, 2020

Class III

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 86406
Status
Terminated
Classification
Class III
Quantity
180 units
Official record key
device-enforcement:Z-0103-2021

Official wording

Reason: 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.

Code information: lot 36870301

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.