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Vitros® versatips and vitros® microtips

Official notice

25 Aug 2023

Last checked

25 Aug 2023

Medium riskHealth Canada

An official Health Canada notice concerns Vitros® versatips and vitros® microtips. Certain proboscis/piston assembly (or assemblies) manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause Vitros® Versatips and/or Vitros® microtips to be improperly seated on the barrel component of the assembly, which may result in an increased frequency of condition codes related to the actions of tip pickup, aspirate, dispense, mix, tip-seal, and discard. Due to the small Vitros® Microtip and Versatip® dimension variability (within manufacturing tolerances) and the way these tips interact with the assembly, Assemblies manufactured within the affected date range may not perform as intended based on the tips currently in use. Recall start date: August 10, 2023 Published 2023-08-25.

What to do now

Review & post notice, discard affected assembly once replacement received, complete/return reply form.

Recall number

74209

Official notice

2023-08-25

The hazard

Certain proboscis/piston assembly (or assemblies) manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause Vitros® Versatips and/or Vitros® microtips to be improperly seated on the barrel component of the assembly, which may result in an increased frequency of condition codes related to the actions of tip pickup, aspirate, dispense, mix, tip-seal, and discard. Due to the small Vitros® Microtip and Versatip® dimension variability (within manufacturing tolerances) and the way these tips interact with the assembly, Assemblies manufactured within the affected date range may not perform as intended based on the tips currently in use. Recall start date: August 10, 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

74209

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Affected products

Product 1

Affected products - Vitros XT 7600 Integrated System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 684 4461

Product 2

Affected products - Vitros 4600 Chemistry System (New & Refurbished), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 6900440 6802445

Product 3

Affected products - Vitros XT 3400 Chemistry System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 684 4458

Risk / hazard

Certain proboscis/piston assembly (or assemblies) manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause Vitros® Versatips and/or Vitros® microtips to be improperly seated on the barrel component of the assembly, which may result in an increased frequency of condition codes related to the actions of tip pickup, aspirate, dispense, mix, tip-seal, and discard. Due to the small Vitros® Microtip and Versatip® dimension variability (within manufacturing tolerances) and the way these tips interact with the assembly, Assemblies manufactured within the affected date range may not perform as intended based on the tips currently in use. Recall start date: August 10, 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: Ortho-clinical Diagnostics, Vitros® Versatips And Vitros® Microtips.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74209

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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