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Microscan Microstrep Panel (March 08, 2013)

Report a Concern
Starting date:
March 08, 2013
Posting date:
March 08, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-26451

Reason

There is an issue of false skipped wells and false susceptible misreads with s. agalactiae affecting multiple antimicrobial agents on Microscan MSP1, MSP5, MF5J and MF7J panels processed in a WalkAway system. The effect is the potential for false susceptible results for s. agalactiae if the walkaway system reads are not verified. This issue is not panel lot specific nor is it related to a particular model of WalkAway instrumentation. No other streptococcal species are affected.

Affected products

Microscan Microstrep Panel (2013-03-08)

Lot or serial number

All lots

Model or catalog number

10444757, B1027-201

Companies

Manufacturer
Not Applicable