Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC has recalled 403 units of OC-Auto FOBT-CHEK Negative Controls due to a labeling error. These materials are used in laboratories to monitor the accuracy of Fecal Occult Blood Tests (FOBT). The labels on the kit boxes and internal vials incorrectly state an expiration date of January 16, 2026, when the product is actually valid until January 17, 2027.
The incorrect label suggests the product expires a year earlier than it actually does. This could lead laboratories to stop using valid test controls prematurely, which might cause confusion or unnecessary disposal of supplies, although the product itself is safe and effective until the corrected 2027 date.
Labeling error affects both the kit box label and individual vial labels.
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Sources: FDA iRES · Raw API Response
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