FDA recall Z-2434-2019

Product

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

Reason for recall

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

Distribution

Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea

Key facts

Status

Terminated

Initiation date

2016-10-14

Report date

2019-09-11

Termination date

2023-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2434-2019