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Microscan Rapid Neg Urine Combo Panel (2014-10-22)
- Starting date:
- October 22, 2014
- Posting date:
- November 7, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42077
Recalled Products
Microscan Rapid Neg Urine Combo Panel
Reason
There is an increase in false susceptible results for Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa isolates on Rapid Neg BP combo Type 3 (B1017-117)and Rapid Neg Urine combo Type 1 (B1017-167) panels, as compared to frozen reference panels, with the four key drugs evaluated (Aztreonam, Cefotaxime, Ceftazidime and Ceftriaxone). The false susceptible results could lead to the potential treatment of patients with an ineffective antibiotic.
Affected products
Microscan Rapid Neg Urine Combo Panel
Lot or serial number
2014-11-01
2015-01-03
2015-02-14
2015-03-21
2015-05-20
2015-06-18
2015-07-18
2015-08-11
Model or catalog number
B1017-167
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
2040 Enterprise Blvd. West
Sacramento
95691
California
UNITED STATES