No image published for this recall

No image published for this recall

Epoc® nxs host – 5553ca

Official notice

17 Nov 2023

Last checked

17 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Epoc® nxs host – 5553ca. Siemens Healthcare Diagnostics Inc. Has confirmed a potential issue that could occur under specific conditions when the (automatic) delete blood tests feature is enabled. When the results are run on the epoc® NXS host and delete blood tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. Recall start date: October 24, 2023 Published 2023-11-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74607

Official notice

2023-11-17

The hazard

Siemens Healthcare Diagnostics Inc. Has confirmed a potential issue that could occur under specific conditions when the (automatic) delete blood tests feature is enabled. When the results are run on the epoc® NXS host and delete blood tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. Recall start date: October 24, 2023

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

74607

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Affected products

Product 1

Affected products - epoc® NXS Host – 5553CA, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11413506

Risk / hazard

Siemens Healthcare Diagnostics Inc. Has confirmed a potential issue that could occur under specific conditions when the (automatic) delete blood tests feature is enabled. When the results are run on the epoc® NXS host and delete blood tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. Recall start date: October 24, 2023

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

Manufacturer

Not provided

Phone

Not provided

Brand: Epocal, Epoc® Nxs Host – 5553ca.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74607

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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