OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Low |
| Status | ongoing |
| Recall date | October 06, 2025 |
| Reported | November 26, 2025 |
| Recalling firm | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC |
| Country / region | United States NY |
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.
Affected products
- OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Related recalls
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