Abbott RealTime CMV (2019-03-26)

Starting date:

March 26, 2019

Posting date:

April 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69778

Last updated: 2019-04-30

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  Reason
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  Affected products

Affected Products

Abbott RealTime CMV

Reason

It has been identified that higher than expected rate of error codes may be observed when using Abbott RealTime CMV Control Kit Lot Number 485936 with the Abbott RealTime CMV assay.

Investigation results have identified that delayed Internal Control (IC) threshold cycle (Ct) including IC failure on Low Positive and/or High Positive Controls with error codes 4442 (Internal Control cycle number is too high) and/or 4457 (Internal Control failed) is associated with specific lots of a supplied subcomponent utilized in the manufacturing of the Abbott RealTime CMV Control Kit.

Affected products