Vidas products (2021-09-26)
- Starting date:
- September 26, 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-76607
Last updated:
2021-10-08
Affected Products
- Vidas - HCG ASSAY
- Vidas - PROGESTERONE ASSAY
- Vidas - C.DIFFICILE TOXIN A & B
- Vidas - B-R-A-H-M-S PCT (PROCALCITONIN) ASSAY
- Vidas - D-DIMER EXCLUSION II
- Vidas SYSTEM - Vidas NT-PROBNP2
- Vidas C. DIFFICILE GDH
- Vidas HIGH SENSITIVE TROPONIN I (TNHS)
Reason
Based on an unusual rate of complaints from the field for "substrate error" leading to a potential delayed results on different Vidas References tested on all Vidas? Systems, Biomerieux initiated an investigation. The substrate error issue was confirmed on all lots of Vidas? Immuno-Assays manufactured with substrate batches using the common lot of raw material (4-MUP). The only potential risk associated with the substrate error is a delayed result as you need to run another test. There is no risk of false results. The investigation demonstrates that the issue occurs over the product shelf-life. The analyzes of the kinetic model allowed to define a revised expiry date for each impacted lot of Vidas? Immuno-Assays finished products. When used until the revised expiry date, the product continues to perform per its registered performance specifications
Affected products
A. Vidas - HCG ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
30405
Companies
- Manufacturer
-
bioMérieux SA
376 Chemin de l'Orme
Marcy-l'Étoile
69280
FRANCE
B. Vidas - PROGESTERONE ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
30409
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE
C. Vidas - C.DIFFICILE TOXIN A & B
Lot or serial number
- 1008731010
- 1008926680
Model or catalog number
30 118
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE
D. Vidas - B-R-A-H-M-S PCT (PROCALCITONIN) ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
30 450
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE
E. Vidas - D-DIMER EXCLUSION II
Lot or serial number
- 1008589450
- 1008815230
- 1008761040
- 1008770900
- 1008778210
- 1008800130
- 1008815200
Model or catalog number
30 455
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE
F. Vidas SYSTEM - Vidas NT-PROBNP2
Lot or serial number
- 1008693930
- 1008747590
- 1008776240
- 1008838180
- 1008851520
- 1008886400
- 1008894100
- 1008894140
Model or catalog number
30 458
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE
G. Vidas C. DIFFICILE GDH
Lot or serial number
- 1008597480
- 1008686700
- 1008859220
Model or catalog number
30 125
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE
H. Vidas HIGH SENSITIVE TROPONIN I (TNHS)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
415386
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE