OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin… — Class III medical device recall Z-0538-2026
Ongoing recall by POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC, reported 2025-11-26, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. A labeling error was identified on the affected product. The expiration date on the kit box label and on the v
| Recall number | Z-0538-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC, Cortlandt Manor, NY, United States |
| Recall initiated | 2025-10-06 |
| Classified | 2025-11-17 |
| Reported by FDA | 2025-11-26 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 403 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00855574005520 |
| Lot numbers | 250805 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0538-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.