VITEK 2 Companct 30 System - Instrument (2018-02-22)

Starting date:

February 22, 2018

Posting date:

March 23, 2018

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-66250

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  Reason
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  Affected products

Affected products

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT

Reason

Internal investigation has demonstrated that in specific cases when a card is processed in, and ejected from, a slot number greater than 15 or 30 (all VITEK 2 Compact Reader Carousels contain 60 physical slots), respectively, the final data packet for the card fails to be accepted by the computer, and the isolate status remains at "preliminary". When the anomaly occurs, subsequent data for current and future cards will not be transferred to the computer until the offending data packet is removed. Since the card has completed processing, as evidenced by the card ejection from the VITEK 2 compact reader, the results indicated in the lab report are the final results. As the card data for the ejected card will be lost after record removal, it is recommended the user print the lab report prior to removal of the record.

Affected products