Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported November 26, 2025
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Polymedco, INC. / Polymedco Cancer Diagnostic Products, LLC recalled OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed… - a low-severity action.
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed… was recalled by Polymedco, INC. / Polymedco Cancer Diagnostic Products, LLC in November 26, 2025. Reason: A labeling error was identified on the affected product. The expiration date on the kit box label and on the …. Check the official notice for the remedy. Verify recall #Z-0538-2026 with the FDA Devices before acting.
The recall
Polymedco, INC. / Polymedco Cancer Diagnostic Products, LLC issued this low-severity FDA Devices recall-A labeling error was identified on the affected product. The expiration date on the kit box label and on the ….
- Low
- severity level
- 403 units
- affected scope
- Class III
- classification
- November 26, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0538-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0538-2026) was formally reported on November 26, 2025, with the manufacturer initiating the action on October 6, 2025. It is classified under Low severity (Class III), with a current status of Ongoing. Polymedco, INC. / Polymedco Cancer Diagnostic Products, LLC is listed as the recalling firm, operating out of Cortlandt Manor, NY. Federal records list the affected scope as 403 units.
The documented reason for this recall is: 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 2027-0… Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
403 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0538-2026 |
| Date reported | November 26, 2025 |
| Date initiated | October 6, 2025 |
| Recalling firm | Polymedco, INC. / Polymedco Cancer Diagnostic Products, LLC |
| Firm location | Cortlandt Manor, NY |
| Affected scope | 403 units |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0538-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test). Recalled by Polymedco, INC. / Polymedco Cancer Diagnostic Products, LLC. Units affected: 403 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Low. Recall number: Z-0538-2026.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0538-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 26, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.