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Recalled Products by Beckman Coulter
- Starting date:
- November 19, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16267
Recalled Products
- Beckman Coulter AU2700 Immunochemistry System - Urinary/CSF Protein
- Beckman Coulter AU 5400 Immunochemistry System - Urinary/CSF Protein
- Beckman Coulter AU Immunochemistry System - Urinary/CSF Protein
Reason
Beckman Coulter has confirmed that a negative shift in quality control and patient sample recovery may be observed at the low end of the measuring range, resulting in an increase in negative results with G flags, when certain device lot numbers are used. Additionally, a blue precipitate has been observed in some reagent vials of these lots.
Affected products
A. Beckman Coulter AU2700 Immunochemistry System - Urinary/CSF Protein
Lot or serial number
3241, 3257
Model or catalog number
OSR6170, OSR6270
Companies
- Manufacturer
- Beckman Coulter Inc.
B. Beckman Coulter AU 5400 Immunochemistry System - Urinary/CSF Protein
Lot or serial number
2917, 2918
Model or catalog number
OSR6170, OSR6270
Companies
- Manufacturer
- Beckman Coulter Inc.
C. Beckman Coulter AU Immunochemistry System - Urinary/CSF Protein
Lot or serial number
2796, 2812
Model or catalog number
OSR6170, OSR6270
Companies
- Manufacturer
- Beckman Coulter Inc.