Mas Omni Cardio
Contact the manufacturer if you require additional information.
|Lot or serial number
|Model or catalog number
|Mas Omni Cardio
|OCRD2503S OCRD2503L OCRD2503U
|OCRD-SP OCRD-UL OCRD-L
Manufacturer initiated recall notifying users of lot-specific open vial stability claim reduction = IFU correction to affected lots. Open vial stability for troponin I present in OCRD-UL, OCRD-I and OCRD-SP does not meet the 15 day claim in IFU. Analysis has demonstrated that the analyte is stable for 5 days once the vial is opened. Informing cosignees prior to use via each unit including a product bulletin and labelling on orange paper with corrected open vial stability.
Recall start date: September 29, 2022
46500 Kato Road, Fremont, California, United States, 94538