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Health product recall

Various ETEST Antimicorbial Susceptibility Tests (2016-12-28)

Starting date:
December 28, 2016
Posting date:
January 25, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61940

Affected Products

  1. ETEST Antimicrobial Susceptibility Testing - Benzylpenicil Pg 256 Ww
  2. ETEST Antimicrobial Susceptibility Testing - Ceftazidime Tz 256 Ww F100
  3. ETEST Antimicrobial Susceptibility Testing - Ciprofloxacin Ci 32 Ww
  4. ETEST Antimicrobial Susceptibility Testing - Fosfomycin Fm 1024 Ww
  5. ETEST Antimicrobial Susceptibility Testing - Gentamicin Gm 256 Ww
  6. ETEST Antimicrobial Susceptibility Testing - Tobramycin Tm 256 Ww
  7. ETEST Antimicrobial Susceptibility Testing - Vancomycin Va 256 Ww
  8. ETEST Antimicrobial Susceptibility Testing- Doripenem Dor 32 Ww

Reason

As part of an ongoing project regarding the analysis of stability data on ETEST range, we have observed a decrease in the shelf life of the following ETEST products that requires your immediate attention to ensure improved use of the product within its revised shelf life of twelve (12) months.

Affected products

  1. ETEST Antimicrobial Susceptibility Testing - Benzylpenicil Pg 256 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 502518
Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

B. ETEST Antimicrobial Susceptibility Testing - Ceftazidime Tz 256 Ww F100

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

506718

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

C. ETEST Antimicrobial Susceptibility Testing - Ciprofloxacin Ci 32 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

508610
508618

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

D. ETEST Antimicrobial Susceptibility Testing - Fosfomycin Fm 1024 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

529100
529108

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

E. ETEST Antimicrobial Susceptibility Testing - Gentamicin Gm 256 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

512510
512518

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

F. ETEST Antimicrobial Susceptibility Testing - Tobramycin Tm 256 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

522718

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

G. ETEST Antimicrobial Susceptibility Testing - Vancomycin Va 256 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

525510
525518

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

H. ETEST Antimicrobial Susceptibility Testing- Doripenem Dor 32 Ww

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

535918

Companies
Manufacturer
Biomerieux Sa
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE