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Vitros Chemistry Products NH3 DT Slides (2014-07-16)
- Starting date:
- July 16, 2014
- Posting date:
- July 25, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40713
Recalled Products
Vitros Chemistry Products NH3 DT Slides
Reason
OCD has determined that the data/calibration mathematics from calibration data module (CDM PROM) 0168 and 0169 for Vitros chemistry products DT calibrator kit, lot 44 required to support Vitros chemistry products NH3 DT slides, generation (GEN) 59, was inadvertently omitted. Without this calibration information, customers will be unable to calibrate or use Vitros NH3 DT slides GEN 59 with Vitros chemistry products DTcalibrator kit lot 44 when CDM PROM 0168 or 0169 is installed on their Vitros DT60/DT60II chemistry system.
Affected products
Vitros Chemistry Products NH3 DT Slides
Lot or serial number
105902254396
105902280237
105902284058
105902284417
Model or catalog number
1532589
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES