FDA-Device2025-11-26Class IIIMISBRANDING
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Hazard
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.
Intended for
Adults
Illnesses reported
None reported
Sold states
USA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, ,WI, WV, WY, Canada: AB, ON
Affected count
403 units
Manufactured in
510 Furnace Dock Rd, Cortlandt Manor, NY, United States
Products
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0538-2026Want us to check the next one for you?
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