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STA - Liquid Anti Xa (2014-07-28)
- Starting date:
- July 28, 2014
- Posting date:
- September 3, 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-41243
Recalled Products
STA - Liquid Anti Xa
Reason
The Stago hotline/call center has received some customer complaints regarding a misreading of reagent 1 (substrate) barcode on STA analyzers. Diagnostica Stago has investigated and confirmed that the barcode is incorrectly coded. Consequently, when the barcode is scanned on STA analyzers, the last 3 digits displayed are "066" instead of "366". When the corresponding flyer is scanned, the STA analyzer displays an error message because the lot of the vial does not match with the lot on the flyer.
Affected products
STA - Liquid Anti Xa
Lot or serial number
112366
Model or catalog number
00311US
Companies
- Manufacturer
-
Diagnostica Stago SAS
9, Rue Des Freres Chausson
Asnieres
92600
FRANCE