MAS™ Omni-CARDIO™
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
MAS™ Omni-CARDIO™ |
OCRD2704U |
OCRD-SP |
MAS™ Omni-CARDIO™ |
OCRD2704M |
OCRD-101 |
MAS™ Omni-CARDIO™ |
OCRD27043 |
OCRD-303 |
MAS™ Omni-CARDIO™ |
OCRD27041 |
OCRD-UL |
MAS™ Omni-CARDIO™ |
OCRD2704S |
OCRD-MP |
MAS™ Omni-CARDIO™ |
OCRD2704L |
OCRD-202 |
MAS™ Omni-CARDIO™ |
OCRD27042 |
OCRD-L |
Issue
Microgenics initiated recall of MAS Omni•CARDIO liquid assayed integrated cardiac control due to reported complaints of vial-to-vial variability when using the control with high sensitivity troponin I assays only (but not with standard/regular troponin I assays). No other analytes are reported to be showing variability between vials. This issue could result in a delay in reporting patient results. If the variability of the material exceeds your lab's specification, dispose of the material.
Additional information
Details
Microgenics Corporation
46500 Kato Road, Fremont, California, United States, 94538
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