Bilirubin Direct Gen. 2 (BILD2) (2019-04-04)

Starting date:

April 4, 2019

Posting date:

May 3, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69820

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

Bilirubin Direct Gen. 2 (BILD2)

Reason

Low control recovery can be observed with BILD2 immediately after cassette opening, with subsequent calibration of the affected cassette failing due to a Sens E error.

Affected products