POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials design…

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0538-2026
• FDA 510(k) clearance · K924061The device's official FDA premarket clearance record
• FDA device classification · JJYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.