FDA-Device2019-09-11Class II
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Helena Laboratories, Inc.
Hazard
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Sold states
Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
Affected count
65 kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2434-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief