Mas Omni Cardio
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Mas Omni Cardio |
OCRD2503S |
OCRD-SP |
Issue
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
Additional information
Details
Microgenics Corporation
46500 Kato Road, Fremont, California, United States, 94538
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