Rappel de produits de santé

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

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

Abbott RealTime CMV

Lot or serial number

485936

Model or catalog number

5N23-80

Companies
Manufacturer

Abbott Molecular Inc.

1300 E. Touhy Ave.

Des Plaines

60018

Illinois

UNITED STATES