Recall record at a glance
| Official record | Z-0538-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Ongoing |
| Recalling firm | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC |
| Report date | Nov 26, 2025 |
| Recall initiation date | Oct 6, 2025 |
| Quantity | 403 units |
| Location | Cortlandt Manor, NY, United States |
Official product description
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Why the product was recalled
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 information
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
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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