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Liaison Aldosterone control sets (2014-12-05)
- Starting date:
- December 5, 2014
- Posting date:
- December 18, 2014
- 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-42935
Recalled Products
A) Liaison Aldosterone control set (588116)
B) Liaison Aldosterone control set (588120)
Reason
The Liaison Aldosterone Control Set IFU contains an error in storage and stability. The control open use stability claim is 6 weeks when stored at 2-8c but the correct control open use stability is 4 weeks when properly stored at 2-8c.
Affected products
A) Liaison Aldosterone control set (588116)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
310451
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Ave. P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES
B) Liaison Aldosterone control set (588120)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
310451
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Ave. P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES