OC-Auto FOBT-CHEK Negative Controls is the negative… recallZ-0538-2026 · Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC · initiated Oct 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it 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.
FDA root cause category: Process control
What the company is doing
On October 6, 2025 URGENT PRODUCT RECALL: INCORRECT EXPIRATION DATE ON PRODUCT LABELING letters were sent to customers. ACTIONS REQUIRED BY YOU 1. Please trace the OCQN kits, lot 250805 in your inventory and at the customer sites listed in appendix one. If the kits have already been used no further action is required. There is no risk to patient care. 2. For customers with remaining stock there are two options:1) Manually correct the date on the packaging and vial labels to 2027-01-17 and add this notification to the kit box. OR 2) Request replacement stock with corrected labeling from Polymedco. ADDITIONAL INFORMATION Polymedco s inventory of Lot 250805 has been updated with new labels with the correct shelf life. All kits provided from September 25, 2025, will have the correct expiration date.
Recall details
- Recall number
- Z-0538-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 6, 2025
- Posted by the FDA
- Nov 17, 2025
- Recalling firm
- Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC
- Quantity
- 403 units
- Product code
- JJY
- FDA submissions
- K924061
- 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
Product description
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Code information (models, lots, serial numbers)
UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FOBT-CHEK OCQNPolymedco Cancer Diagnostic Products LLC · Automated Occult Blood Analyzer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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