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Synchron Systems Aqua Cal 1
- Starting date:
- May 15, 2017
- Posting date:
- June 7, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-63542
Reason
Beckman Coulter has confirmed a negative shift of 5 mmol/L for sodium recovery in Synchron Control level 3 when calibrated with Aqua CAL 1 Lot 72645074. A linearity study using Maine linearity standards also indicated a negative shift of up to 8 mmol/L at values between 150 and 180 mmol/L.
Affected products
Synchron Systems Aqua Cal 1
Lot or serial number
72645074
Model or catalog number
471288
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES