LumiQuick Cardiac Panel Test Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.
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, but the source text does not report any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling the Cardiac Panel Test (Serum), catalog number 75003, all lots. The recall involves products shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance.
The recall was initiated because the products were distributed to facilities that lacked the necessary regulatory approvals. The affected units were distributed in the states of California, Florida, New Jersey, Texas, and New York.
Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
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: 75003
- 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 non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateMycotoxin panel tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateCholesterol tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateMycoplasma genitalium Control Panel Distributed Without Proper Release Testing
FDA (Devices) · 2022-03-23
- ModerateFood allergy IgE panel tests recalled for lacking premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateLyme tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighUnauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
FDA (Devices) · 2023-11-01