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Access AMH QC Kit (2016-06-21)
- Starting date:
- June 21, 2016
- Posting date:
- July 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-59246
Affected products
A. Access AMH QC Kit
Reason
Beckman Coulter determined that the quality control (QC) value card lists incorrect standard deviation (SD) values for the access AMH QC kit lot 689202.the QC value cards for this lot list the following standard deviation values: QC1 as 0.02, QC2 as 0.11 and QC3 as 0.65. The correct standard deviation values are as follows: QC1 is 0.15, QC2 is 0.76 and QC3 is 2.30.
Affected products
A. Access AMH QC Kit
Lot or serial number
689202
Model or catalog number
B13129
Companies
- Manufacturer
-
Immunotech SAS
130 AVENUE DE LATTRE DE TASSIGNY
MARSEILLE CEDEX 09,
13276
FRANCE