Biomerieux Recalls Granada Biphasic Broth Due to Missing FDA Clearance
Biomerieux Inc is recalling 24 cartons of Granada Biphasic Broth because the product lacks required FDA 510(k) clearance for marketing in the United States.
What this means for you
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 driven by a regulatory compliance issue (missing 510(k) clearance) rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 24 cartons of Granada Biphasic Broth, a selective medium used for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. The affected units are identified by REF 42722 and Lot Numbers 896, 897, and 899.
The recall was initiated because the U.S. Food and Drug Administration determined that the product requires 510(k) clearance to continue marketing and distribution in the United States. The product was distributed to the states of California, Georgia, Indiana, Massachusetts, Minnesota, Missouri, New York, Ohio, and Pennsylvania.
Healthcare facilities and consumers who possess this product should stop using it and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
- Manufacturer
- Biomerieux Inc
- Affected units
- 24
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)
- REF 42722 - Lot Numbers 896
- 897 & 899
Distribution
Related recalls
Same manufacturer · Biomerieux Inc
See all →- 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
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 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