Mueller-Hinton Broth with 3% lysed horse blood (2018-03-18)

Starting date:

March 18, 2018

Posting date:

November 28, 2018

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-68384

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  Reason
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  Affected products

Affected products

Mueller-Hinton Broth with 3% lysed horse blood

Reason

Beckman coulter has received customer complaints of lowered minimum inhibitory concentration (mic) for antimicrobial agent’s Cefaclor (CFR) and Penicillin (P) with control organism streptococcus pneumoniae (ATCC 49619) during Quality Control (QC) testing on MICroSTREP plus Panel Type 1 hydrated with the broth lot mentioned above.

The performance issue may be detected by QC. However, if the broth is put into use and QC testing is not performed, or the panels pass QC testing and are used for clinical isolate testing, then there is the potential for false susceptible results due the organism not growing. This may result in progression of infection or failure to control a bacterial infection leading to other complications.

Affected products