BD Phoenix AST / -S Indicator and BD Phoenix AP AST Indicator Bag (2018-12-27)
- Starting date:
- December 27, 2018
- Posting date:
- January 23, 2019
- 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-68880
Affected products
- BD Phoenix AST / -S Indicator
- BD Phoenix AP AST Indicator Bag
Reason
BD has recently confirmed that BD Phoenix panels inoculated using certain lots of BD Phoenix AST Indicator solution are demonstrating an increased occurrence of test aborts within 45 minutes after the panel is placed into the Phoenix instrument. Customers experiencing test aborts receive the following instrument Special Message report: An insufficient amount of indicator was detected in the panel. The AST portion of the panel has been terminated and the isolate should be retested.
Affected products
A. BD Phoenix AST / -S Indicator
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 246004
- 246009
Companies
- Manufacturer
-
Becton Dickinson and Company
7 Loveton Circle
Sparks, Maryland
21152
UNITED STATES
B. BD Phoenix AP AST Indicator Bag
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
246006
Companies
- Manufacturer
-
Becton Dickinson and Company
7 Loveton Circle
Sparks, Maryland
21152
UNITED STATES