The following is a summary of information provided by the licensee via phone and email:
On March 24, 2024, a generator experienced a breakthrough event. The elution from a Curium technetium-99m (Tc-99m) generator did not meet the concentration requirements of 0.15 microcuries molybdenum-99 (Mo-99)/millicurie Tc-99m per 10 CFR 35.204. The generator is from lot number 914024034. The elution contained 1251.3 millicuries of Tc-99m and 203.1 microcuries of Mo-99, resulting in a ratio of 0.16 microcurie Mo-99/millicurie Tc-99m.
The elution was not used to prepare a radiopharmaceutical kit or for dispensing of patient doses. The elution was set aside immediately for decay and disposal. The generator was eluted multiple times following the breakthrough and none of those elutions exceeded the regulatory limit.
Curium, the manufacturer, was notified on 3/29/2024. The generator is being quarantined pending disposal.