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MICROSCAN POS COMBO and POS BREAKPOINT COMBO (2015-11-23)
- Starting date:
- November 23, 2015
- 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-56214
Affected Products
- MICROSCAN POS COMBO
- MICROSCAN POS BREAKPOINT COMBO
Reason
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with quality control (QC) american type culture collection (ATCC) organism staphylococcus aureus ATCC 29213 in the affected panels. The expected result is positive.
The falsely negative result was traced to a single VP component lot used in the manufacturing of the affected panels.
Affected products
A. MICROSCAN POS COMBO
Lot or serial number
- 2016-04-29
- 2016-04-30
- 2016-05-04
- 2016-05-05
Model or catalog number
- B1016-161
- B1017-201
- B1017-211
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
Companies
B. MICROSCAN POS BREAKPOINT COMBO
Lot or serial number
2016-04-29
2016-04-30
2016-05-06
Model or catalog number
B1016-152
B1016-164
B1017-202
B1017-206
B1017-214
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES