Fecal occult blood controls recalled over a wrong expiration date printed
Polymedco is recalling 403 units of OC-Auto FOBT-CHEK Negative Controls because the kit box and vial labels state an expiration date of 2026-01-16 instead of 2027-01-17.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 as a documentation issue: the FDA designated this Class III and the record cites an incorrectly printed expiration date with no product defect.
Plain-English summary
OC-Auto FOBT-CHEK Negative Controls, the negative hemoglobin control material used to monitor fecal occult blood testing, catalog number OCQN, is being recalled.
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated 2026-01-16; the correct expiration date is 2027-01-17.
The recall covers 403 units carrying UDI 00855574005520, from lot 250805, distributed across the United States. The FDA has classified the recall as Class III, its least serious category.
The enforcement record describes a printed date error rather than a product defect, and reports no injuries. Laboratories holding the affected lot should follow the firm's instructions.
The recalled product
- Product
- OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
- Affected units
- 403
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 00855574005520
- Catalog Number(s): OCQN Lot Number(s): Lot 250805
Distribution
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