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COULTER ACT REAGENT KITS (2015-08-24)
- Starting date:
- August 24, 2015
- Posting date:
- October 5, 2015
- 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-55190
Affected Products
- COULTER ACT PAK REAGENT KIT
- COULTER ACT TAINER REAGENT KIT
Reason
Beckman Coulter has received an increased number of service calls and customer complaints related to the hemoglobin (HGB) parameter on the Ac·T Series Analyzers. An investigation revealed that the issues may have been related to variability in a component of the diluents which in turn may lead to a film coating the inside of the WBC bath where the HGB is measured. The issue is not observed with all analyzers.
Affected products
A. COULTER ACT PAK REAGENT KIT
Lot or serial number
- 112077K - 112096K
Model or catalog number
- 8547110
- 8547134
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. COULTER ACT TAINER REAGENT KIT
Lot or serial number
- 113074K - 113088K
Model or catalog number
- 8547111
- 8547135
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES