Biogenex InSite HER-2 Detection Kit Recalled for Lack of FDA Approval
Biogenex Laboratories is recalling four InSite HER-2 Detection Kits distributed in Brazil and Ecuador without FDA 510(k) approval.
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 when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biogenex Laboratories, Inc. is recalling four units of the InSite HER-2 Detection Kit, an immunohistochemistry assay intended for in vitro diagnostic use. The recall is being conducted because the product was distributed without the required FDA 510(k) approval.
The affected products are identified by catalog number RD471-60K and include lot numbers RD4710111 (expiration January 2012), RD4710411 (expiration April 2012), and RD4711013 (expiration October 2014). The source text indicates that these kits were distributed in Brazil and Ecuador, with no distribution in the United States.
Consumers and healthcare providers in the affected regions should stop using the product and contact Biogenex Laboratories for further instructions regarding the recall.
The recalled product
- Product
- InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
- Manufacturer
- Biogenex Laboratories, Inc.
- Affected units
- 4
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 (6)
- Catalog number RD471-60K: Lot numbers: RD4710111
- Exp Jan 2012
- RD4710411
- Exp. Apr 2012
- RD4711013
- Exp Oct 2014.
Distribution
Distribution scope not specified by the agency.
Related recalls
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
- HighImmundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance
FDA (Devices) · 2023-05-24
- ModerateDako HER2 CISH pharmDx Kit Recalled Due to Weak Red Signals
FDA (Devices) · 2014-03-05
- HighFDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations
FDA (Devices) · 2023-01-11
- ModerateDako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration
FDA (Devices) · 2016-07-06
- HighHelena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
FDA (Devices) · 2019-07-17
- HighSiemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data
FDA (Devices) · 2021-11-10