ARCHITECT I System - DHEA-S Assay (2017-12-19)

Starting date:

December 19, 2017

Posting date:

January 8, 2018

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-65576

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  Reason
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  Affected products

Affected products

ARCHITECT I System - DHEA-S Assay

Reason

Abbott has identified that falsely elevated results may be obtained when using the ARCHITECT DHEA-S Assay with samples from infants up to 60 days old. The specific cause of the elevated results is currently under investigation. Although falsely elevated results have only been observed with samples from infants up to 60 days old, the expected values representative data for children up to 10 years old provided in the ARCHITECT DHEA-S reagent insert should not be used as these reference ranges are being reviewed as part of the investigation. All in-date lots of current reagent inventory are impacted.

Affected products