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COULTER S-CAL CALIBRATOR KITS (2015-12-14)
- Starting date:
- December 14, 2015
- Posting date:
- January 18, 2016
- 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-56676
Affected Products
A. COULTER S-CAL CALIBRATOR KITS
Reason
Beckman Coulter has received an increased number of customer complaints observed after S-CAL calibration on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems, and the COULTER LH 750 and LH 780 Hematology Systems. Customers have reported a variety of issues during calibration, including: an increase in H&H check messages, low MCH recover in XB, and low MCHC recovery in XB. These issues are not observed with all analyzers.
Affected products
A. COULTER S-CAL CALIBRATOR KITS
Lot or serial number
113160280 to 113160390
4770-4781
Model or catalog number
179310
624519
628026
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES