CanadaMAS™ Omni‑CARDIO™ liquid assayed integrated cardiac control units with lot/serial numbers OCRD2704U, OCRD2704M, OCRD27043, OCRD27041, OCRD2704S, OCRD2704L and OCRD27042 (catalogue numbers OCRD‑SP, OCRD‑101, OCRD‑303, OCRD‑UL, OCRD‑MP, OCRD‑202 and OCRD‑L) are affected. The product was recalled because vial‑to‑vial variability has been reported when used with high sensitivity troponin I assays, which could delay reporting patient results; no variability was reported with standard troponin I assays and no other analytes are reported to be affected. If the variability of the material exceeds your lab’s specification, dispose of the material, and contact the manufacturer for additional information.
What's being recalled
Companies: Microgenics Corporation, 46500 Kato Road, Fremont, California, United States, 94538.
How to identify it
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD2704U; Model or catalogue number: OCRD-SP
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD2704M; Model or catalogue number: OCRD-101
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD27043; Model or catalogue number: OCRD-303
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD27041; Model or catalogue number: OCRD-UL
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD2704S; Model or catalogue number: OCRD-MP
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD2704L; Model or catalogue number: OCRD-202
Affected products: MAS™ Omni-CARDIO™; Lot or serial number: OCRD27042; Model or catalogue number: OCRD-L
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States