Z-0538-2026Class III

OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT...

Name: Z-0538-2026 OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT...
Creator: Polymedco, Inc. / Polymedco Cancer Diagnostic Products, Llc
Published: 2025-10-06
License: https://open.fda.gov/license/

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC / initiated 2025-10-06 / Open, Classified / root cause: manufacturing process

FDA source

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC began a recall of OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test) on 2025-10-06. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0538-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-10-06
Posted: 2025-11-17
Recalling firm: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC
Product: OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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.
Root cause tag: manufacturing process
FDA 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 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 commerce: 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
Product codes and lots: UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0538-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0538-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-17

Product code JJY

K924061Class ICancer Antigen ControlPolymedco, Inc. / cleared 1993-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)