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Health product recall

Salmonella Antiserum H:t

Starting date:
January 17, 2017
Posting date:
February 9, 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-62128

Reason

A decrease in antibody level was detected in this lot which means that agglutination with salmonella strains having weak expression of H:g,m,s,t and H:f,g,t appears after the definition of a positive reaction (10 sec), and therefore would be conceived as negative when in fact it is a positive.

Affected products

Salmonella Antiserum H:t

Lot or serial number

696H-H6

Model or catalog number

40336

Companies

Manufacturer
SSI DIAGNOSTICA A/S
2 HERREDSVEJEN
HILLROD
3400
DENMARK