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U.S. Department of Health and Human Services

Class 3 Device Recall OCAuto FOBTCHEK Negative Control

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 Class 3 Device Recall OCAuto FOBTCHEK Negative Controlsee related information
Date Initiated by FirmOctober 06, 2025
Date PostedNovember 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0538-2026
Recall Event ID 97860
510(K)NumberK924061 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductOC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Code Information UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
Recalling Firm/
Manufacturer		 POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
510 Furnace Dock Rd
Cortlandt Manor NY 10567-6220
For Additional Information ContactMariah Nieves
914-293-0924
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce403 units
DistributionUSA: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJY
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