LumiQuick Tuberculosis Antibody Test Card Serum Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Tuberculosis Antibody Test Card Serum because it was shipped to locations without required FDA 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 and involves a regulatory compliance issue (shipping without clearance) rather than a direct physical hazard or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Tuberculosis Antibody Test Card Serum (Catalog number 71062). 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. This recall is classified as Class II by the FDA.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- 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: 71062
- 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 THC Test Cards Recalled for Unauthorized Distribution
FDA (Devices) · 2014-04-16
- 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
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
- ModerateDermamedics Serum Recalled for Lacking FDA Approval
FDA (Drugs) · 2014-08-06
- HighAmeditech Recalls First Check 1 Panel Drug Cup Due to Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAMS Uric Acid Test Kits Recalled for Regulatory Violations
FDA (Devices) · 2014-04-02
- ModerateAmeditech Recalls First Check 2 Panel Drug Cups Due to Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAMS AST Diagnostic Kits Recalled for Marketing Outside 510(k) Requirements
FDA (Devices) · 2014-04-02
- ModerateLyme tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10