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Microscan Pos Combo Panel Type 43 and Mic Panel Type 34 (2017-04-17)
- Starting date:
- April 17, 2017
- Posting date:
- May 16, 2017
- 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-63294
Affected Products
A. Microscan Pos Combo Panel Type 43
B. Microscan Pos Mic Panel Type 34
Reason
Beckman coulter did not inform the customer that TigeCycline minimum inhibitory concentration (MIC) is being transmitted to the LIS interface data stream. In order to support communication with all LIS systems, the LabPro software is transmitting the TigeCycline MIC value. Some LIS systems can only accept numerical values for antimicrobial agent test results and any interpretive criteria applied to these numerical values are generated by the LIS system.
Affected products
A. Microscan Pos Combo Panel Type 43
Lot or serial number
Not Lot Specific
Model or catalog number
B1017-217
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Microscan Pos Mic Panel Type 34
Lot or serial number
Not Lot Specific
Model or catalog number
B1017-216
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES