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VIDAS - PROGESTERONE ASSAY (2014-11-25)
- Starting date:
- November 25, 2014
- Posting date:
- April 13, 2015
- 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-52819
Recalled Products
A. VIDAS - PROGESTERONE ASSAY
Reason
Complaints have been received about the values of the kit control (C1) referenced in the MLE card. During the investigation (PR 811293) it was discovered that the dose value range and the confidence interval of the C1 control referenced in the MLE card was different than the C1 control referenced in the kits. The dose value range and the confidence interval reported in the mle card are incorrect (dose value range: 3.45 ng/mL, confidence interval: 2.67-4.23 ng/mL).
Affected products
A. VIDAS - PROGESTERONE ASSAY
Lot or serial number
1003335870
Model or catalog number
30409
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE