OC-Auto FOBT-CHEK Controls (Polymedco) – labeling error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Brand
POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
Lot Codes / Batch Numbers
UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
Products Sold
UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC is recalling OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor due to 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 expira. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC
Page updated: Jan 10, 2026