Aptima HIV-1 Quant Assay (2020-12-15)

Starting date:

December 15, 2020

Posting date:

January 15, 2021

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-74751

Last updated:
2021-01-15

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  Reason
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  Affected products

Affected Products 

Aptima HIV-1 Quant Assay

Reason

This recall is due to intermittent invalid runs associated with the Aptima Quant HIV-1 Assay, PRD-03565, lot # 281071A. The first complaints were received from US customers in mid-October 2020; it was in early December, after considerable troubleshooting, that a correlation between the performance of the lot and the customer complaints were made.

Affected products