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DURACLONE B27 (2016-05-02)
- Starting date:
- May 2, 2016
- Posting date:
- May 16, 2016
- 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-58422
Affected Products
DURACLONE B27
Reason
Beckman Coulter has identified that the reagent lot identified above was inadvertently released to market despite not meeting its full product specification. The HLA-B27 Median Fluorescence Intensity (MDFI) of this lot is higher than lots meeting the product specification, which may lead to: (1) an indicated result in the indeterminate zone when the true result is in the negative range, or (2) an indicated result in the positive range when the true result is in the indeterminate zone. The issue was discovered on 2016, March 21 during periodic review of our batch records. There has been no report of death or injury related to this defect.
Affected products
DURACLONE B27
Lot or serial number
- 210116
Model or catalog number
- B36862
Companies
- Manufacturer
-
BECKMAN COULTER INDIA PRIVATE LIMITED
50-B, II PHASE, PEENYA INDUSTRIAL
BANGALORE
INDIA