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Emit Ethosuximide Assay
- Starting date:
- November 15, 2016
- Posting date:
- December 5, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-61286
Reason
Siemens Healthcare Diagnostics has confirmed the Emit Ethosuximide Assay (etho) Reagent Lot H1 fails to calibrate on the Viva-E, V-Twin, Viva ProE, and AU Clinical Chemistry Systems (AU analyzers) when tested with the Emit Antiepileptic Drug (AED) Calibrator Lot H1. The calibration failure will not allow the user to accept and store the calibration.
All other in date Emit Ethosuximide lots successfully pass calibration when tested with the emit AED Calibrator Lot H1.
Affected products
Emit Ethosuximide Assay
Lot or serial number
H1
Model or catalog number
6E119UL
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES