LumiQuick Fecal Occult Blood Test Cards Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards because they were shipped to locations without approved FDA applications or clearances.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a regulatory compliance issue rather than a direct physical safety defect, and no injuries or illnesses are reported.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards, catalog number 72001, all lots. The recall was initiated because the products were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. The recall covers all lots of the product.
Consumers who have these products should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
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)
- Catalog number: 72001
- All lots
Distribution
Part of a larger recall action
This product is one of 80 recalled by LumiQuick Diagnostics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 80 products in this recall →Related recalls
Same manufacturer · LumiQuick Diagnostics Inc.
See all →- ModerateLumiQuick Morphine Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Dengue Test Cards Recalled for Lack of FDA Clearance
FDA (Devices) · 2014-04-16
- ModerateLumiQuick PSA Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick EDDP Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Rotavirus Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
Same hazard · regulatory violation
See all →- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step P in vitro diagnostic test lacks FDA premarket clearance
FDA (Devices) · 2026-05-13
- HighGreen Reviver juice distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20
- HighCucumber mint lemonade distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20
Similar recalls
- ModerateFecal occult blood tests recalled for distribution without premarket clearance
FDA (Devices) · 2025-12-10
- LowMcKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues
FDA (Devices) · 2019-04-10
- LowFecal occult blood controls recalled over a wrong expiration date printed
FDA (Devices) · 2025-11-26
- HighDiagnostic test products recalled by Universal Meditech for missing FDA clearance
FDA (Devices) · 2023-11-01
- HighFDA Recalls Multiple Unauthorized Diagnostic Test Products by Universal Meditech
FDA (Devices) · 2023-11-01
- HighUnauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
FDA (Devices) · 2023-11-01