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LP(A) SPQ II Reagent Set (2013-12-18)
- Starting date:
- December 18, 2013
- Posting date:
- January 17, 2014
- 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-37599
Recalled products
- LP(A) Spq II Reagent Set
Reason
Instability in the LP(A) antibody is causing calibrator absorbance rates to increase.
Affected products
A. LP(A) Spq II Reagent Set
Lot or serial number
- 130172
- 130172A
Model or catalog number
- 86084
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Ave. P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES