MassCheck Cortisol, Cortisone Saliva Control Level 1 & II (2019-09-07)

Starting date:

September 7, 2019

Posting date:

November 15, 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-71593

Last updated: 2019-11-15

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  Reason
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  Affected products

Affected Products

1. MassCheck Cortisol, Cortisone Saliva Control Level 1
2. MassCheck Cortisol, Cortisone Saliva Control Level II

Reason

The batches on the market of order no 730390, 0349 and 0350 show a time-dependent stability ­related deviation from the target values. Using the affected calibrator batches may result in increased results of patient samples, with a positive bias of approx. 15 % detectable. However the measured concentrations are still within the Chromsystems internal acceptance criteria.

Affected products