# FDA recall Z-0538-2026

> **POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC** · Class III · device recall initiated 2025-10-06.

## Product

OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor  FOBT (Fecal Occult Blood Test)

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-0538-2026
- **Recalling firm:** POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-06
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cortlandt Manor, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0538-2026

## Citation

> AI Analytics. FDA recall Z-0538-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0538-2026. Source: US FDA. Licensed CC0.

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