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Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
- Starting date:
- December 29, 2016
- Posting date:
- January 18, 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-61844
Reason
As part of post-market surveillance activities, the devices were found to have reduced specificity (90% now versus 99% before). It is only the positive predictive value that is affected. The affected lots' negative predictive value remains unchanged.
Affected products
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
Lot or serial number
- 161003112913JG
- 161007110553JG
- 161010145035NZ
- 161013081750KH
- 161019161504NZ
- 161028142817JH
Model or catalog number
- CR2003
Companies
- Manufacturer
-
IMMUNO MYCOLOGICS INC. (IMMY)
2700 TECHNOLOGY PLACE
Norman
73071
Oklahoma
UNITED STATES