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IMMAGE IMMUNOCHEMISTRY SYSTEMS KAPPA LIGHT CHAIN (KAP) (2017-11-03)
- Starting date:
- November 3, 2017
- Posting date:
- December 8, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65356
Affected products
IMMAGE IMMUNOCHEMISTRY SYSTEMS KAPPA LIGHT CHAIN (KAP)
Reason
Beckman Coulter has determined that KAP lot m611357 may demonstrate inaccuracy or imprecision in control samples containing low concentration kappa light chains. KAP control failures can potentially lead to a delay in reporting kappa light chain patient results. Reassessment of past results is not required. Patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.
Affected products
IMMAGE IMMUNOCHEMISTRY SYSTEMS KAPPA LIGHT CHAIN (KAP)
Lot or serial number
M611357
Model or catalog number
446440
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES