ST AIA-PACK FT3 (2018-12-04)
- Starting date:
- December 4, 2018
- Posting date:
- January 8, 2019
- 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-68690
Affected products
ST AIA-PACK FT3
Reason
Product labeling for the AIA Assay do not indicate the potential for fluorescein interference. Presence of fluorescein may cause elevated test results.
Affected products
ST AIA-PACK FT3
Lot or serial number
All lots, contact manufacturer
Model or catalog number
- 025286
Companies
- Manufacturer
-
Tosoh Corporation
Shiba-Koen First Bldg, 3-8-2, Shiba Minato-Ku
Tokyo
105-8623
JAPAN