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FOLATE III (2016-05-05)
- Starting date:
- May 5, 2016
- Posting date:
- May 24, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-58520
Affected products
- FOLATE III
Reason
A situation was reported to Roche regarding Folate III reagent kit lot 189895-01 that was released from the production line and did not contain the reagent nor the pretreatment. The frequency of occurrence is considered to be very lot (less than 0.1%).
Affected products
A. FOLATE III
Lot or serial number
18989501
Model or catalog number
04476433190
255274
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY