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Immage Immunochemistry Systems Properdin Factor B and Vigil Protein Control (2013-09-18)
- Starting date:
- September 18, 2013
- Posting date:
- October 31, 2013
- 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-36475
Recalled Products
A. Immage Immunochemistry Systems Properdin Factor B
B. Vigil Protein Control
Reason
Beckman Coulter has confirmed differences in recovery of PFB in Vigil protein control using PFB reagent lots M206298, M301364, M302049 compared to values obtained using previous PFB reagent lots. These control differences are due to a change in the pool of antiserum material that is used in the manufacture of the PFB reagent. The control range tables included in Vigil protein control lots M210051, M210052 and M210053 do not reflect PFB values obtained with PFB reagent lots M206298, M301364 and M302049.
Affected products
A. Immage Immunochemistry Systems Properdin Factor B
Lot or serial number
- M206298
- M301364
- M302049
Model or catalog number
- 447760
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Vigil Protein Control
Lot or serial number
- M210051 (Level 1)
- M210052 (Level 2)
- M210053 (Level 3)
Model or catalog number
- 450120
- 450125
- 450130
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES