Health product recall

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

  1. Vidas - HCG ASSAY
  2. Vidas - PROGESTERONE ASSAY
  3. Vidas - C.DIFFICILE TOXIN A & B
  4. Vidas - B-R-A-H-M-S PCT (PROCALCITONIN) ASSAY
  5. Vidas - D-DIMER EXCLUSION II
  6. Vidas SYSTEM - Vidas NT-PROBNP2
  7. Vidas C. DIFFICILE GDH
  8. 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