VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage
Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves diagnostic test kits where storage conditions were exceeded, preventing the manufacturer from guaranteeing performance. This represents a risk-of-harm product where diagnostic failure could lead to unreliable Salmonella detection. No illnesses or injuries have been reported.
Plain-English summary
Biomerieux Inc. is recalling VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702, Batch 1009406530) distributed nationwide due to storage conditions that exceeded acceptable temperature and time parameters. Approximately 15 units were affected.
The test kits were stored outside of approved conditions, which means the manufacturer cannot guarantee their performance in detecting Salmonella infections.
No illnesses or injuries have been reported in connection with this recall. However, affected test kits may produce unreliable diagnostic results.
Customers who have received these test kits should contact Biomerieux Inc. for further instructions on this recall.
The recalled product
- Product
- VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
- Manufacturer
- Biomerieux Inc
- Affected units
- 15
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/DI 03573026065874
- Batch Numbers: 1009406530
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux 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 94 products in this recall →Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
Same hazard · storage damage
See all →- HighVITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance
FDA (Devices) · 2023-01-11
- ModerateDiagnostic Test Kit Recalled Due to Exceeded Storage Conditions
FDA (Devices) · 2023-01-11
- HighVITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance
FDA (Devices) · 2023-01-11
- ModerateLaboratory Culture Medium Recalled Due to Storage Condition Failure
FDA (Devices) · 2023-01-11
- HighTEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion
FDA (Devices) · 2023-01-11
Similar recalls
- ModerateBiomerieux Recalls VIDAS CMV IgM Tests Due to Calibration Issues
FDA (Devices) · 2021-04-21
- HighBiomerieux VIDAS 3 Immunoanalyzer Recalled for False Results Due to Software Error
FDA (Devices) · 2020-02-12
- ModerateVIDAS LH diagnostic test substrate error causes delayed results
FDA (Devices) · 2022-01-05
- HighVIDAS CMV IgM diagnostic test kits recalled for invalid calibrations
FDA (Devices) · 2022-10-05
- HighVIDAS Estradiol II Test Device Recalled Due to Substrate Error
FDA (Devices) · 2022-01-05
- HighT-Cell Xtend Test Kit Recalled Due to Improper Storage Temperature
FDA (Devices) · 2022-09-07