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Health product recall

ST AIA-PACK PROG II ASSAY (2017-11-29)

Starting date:
November 29, 2017
Posting date:
December 21, 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-65448

ST AIA-PACK PROG II ASSAY

Reason

An urgent field safety notice was released to provide updated cross-reactivity information for the progesterone assay urging caution when interpreting results for patients treated with DHEA.

Affected products

ST AIA-PACK PROG II ASSAY

Lot or serial number

All lots

Model or catalog number

25239

Companies

Manufacturer
Tosoh Corporation
Shiba-Koen First Bldg
3-8-2
105-8623
JAPAN