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

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  Reason
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  Affected products

Affected products

1. BD Phoenix AST / -S Indicator
2. 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