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V-Lyte Dilution Check
- Starting date:
- April 24, 2017
- Posting date:
- May 16, 2017
- 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-63308
Reason
Siemens Healthcare Diagnostics has confirmed a high rate of dilution check relative bias failures of greater than 2% when using V-Lyte dilution check solution lots KC6D01, KC6F01, or KC6J01. Newer lots of dilution check starting with KC7A01 are not affected by this issue.
Affected products
V-Lyte Dilution Check
Lot or serial number
KC6D01
KC6F01
KC6J01
Model or catalog number
K840
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES