MAS™ Omni-CARDIO™
Brand(s)
Last updated
Summary
Product
MAS™ Omni-CARDIO™
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Microgenics Corporation
46500 Kato Road, Fremont, California, United States, 94538
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78304
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