OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult
Summary
The FDA issued a Class III for OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials by POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. 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 expira.
Details
Source
Device Recall
External ID
Z-0538-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Lot/Code Info: UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
Quantity Affected: 403 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-06
Company
Cortlandt Manor, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC have FDA actions?
This is the only FDA action we have on record for POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0538-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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