TAQPATH COVID-19 RT-PCR KIT & APPLIED BIOSYSTEMS COVID-19 INTERPRETIVE SOFTWARE (2020-10-09)
- Starting date:
- October 9, 2020
- Posting date:
- October 23, 2020
- 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-74161
Last updated:
2020-10-22
Affected Products
A. TAQPATH COVID-19 COMBO KIT
B. TAQPATH COVID-19 RT-PCR KIT
C. APPLIED BIOSYSTEMS COVID-19 INTERPRETIVE SOFTWARE
D. APPLIED BIOSYSTEMS COVID-19 INTERPRETIVE SOFTWARE
Reason
The first issue is related to the MS2 assay which detects the Internal Positive Control (IPC). We have made a software update to the MS2 settings to reduce the risk of invalid, potential false negatives, or inconclusive tests and to decrease the retest burden on customers. Analysis settings for other targets have not been changed.
The second issue is related to instructions for vortexing and centrifugation of RT-PCR reaction plates. Failure to adequately vortex and centrifuge reaction plates during processing may result in anomalous fluorescence and/or an irregular baseline at the beginning of cycling, interfering with analysis and potentially leading to inconclusive or false positive results.
Affected products
A. TAQPATH COVID-19 COMBO KIT
Lot or serial number
Not applicable.
Model or catalog number
A47814
A47817
Companies
- Manufacturer
-
Thermo Fisher Scientific
168 Third Avenue, Waltham
Massachusetts
02451
UNITED STATES
B. TAQPATH COVID-19 RT-PCR KIT
Lot or serial number
Not applicable.
Model or catalog number
A47817
Companies
- Manufacturer
-
Thermo Fisher Scientific
168 Third Avenue, Waltham
Massachusetts
02451
UNITED STATES
C. APPLIED BIOSYSTEMS COVID-19 INTERPRETIVE SOFTWARE
Lot or serial number
Not applicable.
Model or catalog number
COVID-19 SOFTWARE V1.2
Companies
- Manufacturer
-
Thermo Fisher Scientific
168 Third Avenue, Waltham
Massachusetts
02451
UNITED STATES
D. APPLIED BIOSYSTEMS COVID-19 INTERPRETIVE SOFTWARE
Lot or serial number
Not applicable.
Model or catalog number
COVID-19 SOFTWARE V2.0
Companies
- Manufacturer
-
Thermo Fisher Scientific
168 Third Avenue, Waltham
Massachusetts
02451
UNITED STATES