Device product
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Z-0538-2026
Product summary
- Event
- Event 97860
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 403 units
- Official record key
device-enforcement:Z-0538-2026
Official wording
Reason: 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.
Code information: UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
labeling error