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Au Lyophilized Chemistry Calibrator (2017-08-28)
- Starting date:
- August 28, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64558
Affected products
Au Lyophilized Chemistry Calibrator
Reason
Unpaired lots of au lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. Paired calibrator lots are identified by the last two digits of the lot number. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results.
Affected products
Au Lyophilized Chemistry Calibrator
Lot or serial number
6101K51
Model or catalog number
DR0070-1
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES