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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