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IRISPEC CA/CB/CC (2016-04-11)
- Starting date:
- April 11, 2016
- Posting date:
- April 22, 2016
- 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-58030
Affected products
A. IRISPEC CA/CB/CC
Reason
Iris International has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the IRIspec CA bilirubin control material. The IRIspec CA control may fail for the bilirubin analyte. The laboratory will be unable to process patient samples until QC passes. Not all bottles within a specific lot may be affected.
Affected products
A. IRISPEC CA/CB/CC
Lot or serial number
004-16
006-16
019-16
021-16
336-15
343-15
Model or catalog number
475-1227
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue
Chatsworth
UNITED STATES