Bracco Recalls CardioGen-82 Generators Due to Strontium-82 Levels Exceeding Limits
Bracco Diagnostics is recalling 54 CardioGen-82 generators because Strontium-82 levels exceeded the alert limit specification.
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 classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a GMP deviation regarding radionuclidic purity rather than a direct acute safety failure like a structural defect or contamination with a known pathogen.
Plain-English summary
Bracco Diagnostics Inc. is recalling 54 units of CardioGen-82 (Rubidium Chloride Rb-82) generators. The recall was initiated due to a Good Manufacturing Practice (GMP) deviation where Strontium-82 (Sr-82) levels exceeded the alert limit specification.
The affected products are identified by lot numbers 09101-121251 and 09101-121391. These generators were distributed nationwide and in the United Kingdom. The product is a prescription-only medical device used for the elution of sterile nonpyrogenic Rubidium Chloride Rb-82.
Healthcare providers and facilities should stop using the affected generators and contact Bracco Diagnostics for instructions on return or disposal. Patients who have received the product should consult their healthcare provider if they have concerns.
The recalled product
- Product
- CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82)
- Brand
- CARDIOGEN-82
- Manufacturer
- Bracco Diagnostics Inc
- Affected units
- 54
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 (1)
- Lot numbers 09101-121251 and 09101-121391
Distribution
Distributed nationwide across the United States.
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