Recall Monitor
Health Products

MAS™ Omni-CARDIO™

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: MAS™ Omni-CARDIO™
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
MAS™ Omni-CARDIO™OCRD2704UOCRD-SP
MAS™ Omni-CARDIO™OCRD2704MOCRD-101
MAS™ Omni-CARDIO™OCRD27043OCRD-303
MAS™ Omni-CARDIO™OCRD27041OCRD-UL
MAS™ Omni-CARDIO™OCRD2704SOCRD-MP
MAS™ Omni-CARDIO™OCRD2704LOCRD-202
MAS™ Omni-CARDIO™OCRD27042OCRD-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.

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