Health product recall

Cetrimide Agar (CET) (2019-10-28)

Starting date:
October 26, 2019
Posting date:
January 6, 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-71975



Last updated: 2020-01-07

Affected Products

Cetrimide Agar (CET)

Reason

Fertility issue on cetrimide agar. All impacted lots manufactured with the same semi finished product formulation, Biomerieux observed a low growth of pseudomonas aeruginosa ATCC 10145 (used in clinical bacteriology) and no (for one plate) or low growth for pseudomonas aeruginosa ATCC 9027 (used in industry bacteriology).

Affected products

Cetrimide Agar (CET)

Lot or serial number

1007392590

1007475130

1007512190

1007530990

Model or catalog number

43565

Companies
Manufacturer

BioMérieux S.A

376 Chemin De L'orme

Marcy-l'etoile

69280

FRANCE