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# FDA Cautions on Rubidium 82 Generators in PET
- URL: https://www.fdaweb.com/fda-cautions-on-rubidium-82-generators-in-pet/
- Published: 2019-04-30T12:00:00.000Z
- Updated: 2026-09-15T01:23:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143987

FDA says it is aware of recent incidents that caused excess radiation exposure to patients due to user error with certain systems used to produce rubidium Rb 82 injection for use with positron emission tomography (PET) myocardial perfusion imaging scans. An agency online [notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-reminds-imaging-facilities-follow-safety-procedures-rubidium-82-generators-used-positron?utm%5Fcampaign=FDA%20reminds%20imaging%20facilities%20to%20follow%20safety%20procedures%20for%20rubidium%2082&utm%5Fmedium=email&utm%5Fsource=Eloqua) says FDA is requiring safety labeling changes, including a Boxed Warning, on the labels of rubidium 82 generators to remind systems users to use the correct solution to elute the generator and carefully follow safety procedures for the system.

The notice says that the two systems used in imaging scans — CadioGen-82 and Ruby-Fill (rubidium Rb 82 generator) — require additive-free 0.9% sodium chloride injection USP to safely elute the system. FDA says incidents have been reported to it where an incorrect solution was used to elute the generator, including calcium-containing solutions such as lactated ringers. The calcium in the solution interacts with radioactive strontium 82 and strontium 85 in the generator’s structure. The radioisotopes of strontium then “break through” into the rubidium injection administered to patients, FDA says. The strontium isotopes can deposit high levels of radioactivity in organs including the bone, which can lead to suppressed bone marrow function and suppression of the immune system. The agency says additional long-term risks could include radiation-induced cancers.