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Recall Observatory FDA recall evidence

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

October 06, 2025

Class III

Product summary

Firm
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
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

    reason.labeling_packaging · v1.0.0

    labeling error