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Health product recall

Autodelfia Neonatal 17a-Oh-Progesterone Kit

Starting date:
May 12, 2017
Posting date:
June 7, 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-63524

Reason

Manufacturer has become aware that the component name on the label of some of the 17-ohp assay buffer bottles of the lot 653513 is incorrectly labeled Neo-TSH assay buffer. The lot number and expiry date are correctly printed on all component labels.

Affected products

Autodelfia Neonatal 17a-Oh-Progesterone Kit

Lot or serial number

1065419901

Model or catalog number

B024-112

Companies

Manufacturer
Wallac Oy
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND