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Sunquest ix lis component driver (sisixlil) v8.00.0013 used with instrument manager core version 8.00 and higher.

Official notice

3 Jul 2024

Last checked

3 Jul 2024

Medium riskHealth Canada

An official Health Canada notice concerns Sunquest ix lis component driver (sisixlil) v8.00.0013 used with instrument manager core version 8.00 and higher.. When processing aliquot laboratory orders that include associated patient data, the aliquot instruction may be associated with an incorrect parent specimen tube when multiple samples are in one loadlist from the Laboratory Information System (LIS). Recall Start Date: June 3, 2024 Published 2024-07-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75781

Official notice

2024-07-03

The hazard

When processing aliquot laboratory orders that include associated patient data, the aliquot instruction may be associated with an incorrect parent specimen tube when multiple samples are in one loadlist from the Laboratory Information System (LIS). Recall Start Date: June 3, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75781

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Affected products

Product 1

Affected products - Sunquest IX LIS Component Driver (Sisixlil) V8.00.0013 Used With Instrument Manager Core Version 8.00 And Higher., Lot or serial number - Core versions 8.00 and higher., Model or catalog number - V8.00 AND HIGHER

Risk / hazard

When processing aliquot laboratory orders that include associated patient data, the aliquot instruction may be associated with an incorrect parent specimen tube when multiple samples are in one loadlist from the Laboratory Information System (LIS). Recall Start Date: June 3, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Data Innovations, Sunquest Ix Lis Component Driver V8.00.0013 Used With Instrument Manager Core Version 8.00 And Higher.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75781

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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