Health product recall

Biomeme SARS-CoV-2 Real-Time RT-PCR Test (2021-07-22)

Starting date:
July 22, 2021
Posting date:
October 8, 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-76597

Last updated: 2021-10-08

Affected Products

Biomeme SARS-CoV-2 Real-Time RT-PCR Test

Reason

Unreleased unapproved firm was loaded onto a Thermocycler and shipped to a customer in Canada.  This was discovered during a routine survey of customer data on July 8th, 2021.

Affected products

Biomeme SARS-CoV-2 Real-Time RT-PCR Test

Lot or serial number
  • Version 6.5.0
  • version 6.4.4
Model or catalog number

1000003

Companies
Manufacturer
Biomeme Inc.
1015 Chestnut Street, Suite 1401
Philadelphia
19107
Pennsylvania
UNITED STATES