LIAISON Control Measles IgM (2018-08-10)
- Starting date:
- August 10, 2018
- Posting date:
- August 24, 2018
- 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-67598
Affected products
LIAISON Control Measles IgM
Reason
Positive controls, Part nos. 3500090 and 3500100, in the affected kit lots may result high out of the certificates of analysis range when tested on LIAISON xl in conjunction with liaison measles IgM kit (ref 318820) lot nos. 174017 and 174018. If this combination of kit and control produces a valid run (i.e. calibrators and controls are within established ranges), results can be reliably reported.
Affected products
LIAISON Control Measles IgM
Lot or serial number
- 175012
- 175013
- 175013A
Model or catalog number
318821
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Avenue, P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES