Device recall
Z-0538-2026: OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials…
FDA device recall · Class III · POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
Key facts
| Recall number (Z-number) | Z-0538-2026 |
|---|---|
| Recall event | 97860 |
| Product | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test) |
| Product code | JJY |
| Recalling firm | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K924061 |
| FEI number | 1000119795 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database