Recall Z-0538-2026 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
| Date | Nov 17, 2025 (initiated Oct 6, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 Polymed |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924061 | CANCER ANTIGEN CONTROL Polymedco, Inc., Feb 23, 1993 |