FDA recall Z-0103-2021

Product

Tina-quant Complement C4 ver.2, Catalog 05991994190

Reason for recall

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.

Distribution

Domestic distribution nationwide.

Key facts

Status

Terminated

Initiation date

2020-08-27

Report date

2020-10-21

Termination date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0103-2021