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Navios Lasers (2013-08-22)
- Starting date:
- August 22, 2013
- Posting date:
- October 25, 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-36379
Recalled products
- Navios 8 Colors / 2 Lasers
- Navios 10 Colors / 3 Lasers
Reason
Beckman Coulter has determined that the Navios Flow Cytometer instructions for use (IFU) states that when a drip chamber level warning occurs, the instrument will acquire for at least 5 minutes longer after the drip chamber level warning message is displayed. However, the system may only acquire for as little as 3 minutes after the drip chamber level warning and will provide drip chamber level error. At that time, the instrument will abort acquisition and does not save the listmode file, and data are lost.
Affected products
A. Navios 8 Colors / 2 Lasers
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- A52102
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES
B. Navios 10 Colors / 3 Lasers
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- A52103