Public recall detail

Vitros® Versatips and Vitros® Microtips

2023-08-25

medium
Recall Safety notice
Quick summary

Quick summary: Vitros® Versatips and Vitros® Microtips. Date: 2023-08-25.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Vitros® Versatips and Vitros® Microtips. Date: 2023-08-25.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandORTHO-CLINICAL DIAGNOSTICS INC.
ProductVitros® Versatips and Vitros® Microtips
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74209

Affected products

ProductVitros 3600 Immunodiagnostics System (New & Refurbished)
LotMore than 10 numbers, contact manufacturer.
Model680 2914 680 2783
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 3600 Immunodiagnostics System (New & Refurbished)
ProductVitros XT 7600 Integrated System
LotMore than 10 numbers, contact manufacturer.
Model684 4461
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros XT 7600 Integrated System
ProductVitros 4600 Chemistry System (New & Refurbished)
LotMore than 10 numbers, contact manufacturer.
Model6900440 6802445
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 4600 Chemistry System (New & Refurbished)
ProductVitros 4600 Chemistry System (New & Refurbished)
LotMore than 10 numbers, contact manufacturer.
Model6900440 6802445
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 4600 Chemistry System (New & Refurbished)
ProductVitros 5.1 FS Chemistry System (New & Refurbished)
LotMore than 10 numbers, contact manufacturer.
Model6801375 6801890
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 5.1 FS Chemistry System (New & Refurbished)
ProductVitros XT 3400 Chemistry System
LotMore than 10 numbers, contact manufacturer.
Model684 4458
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros XT 3400 Chemistry System
ProductVitros 5.1 FS Chemistry System (New & Refurbished)
LotMore than 10 numbers, contact manufacturer.
Model6801375 6801890
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 5.1 FS Chemistry System (New & Refurbished)
ProductVitros 5600 Integrated System (New & Refurbished)
LotMore than 10 numbers, contact manufacturer.
Model680 2413 680 2915
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 5600 Integrated System (New & Refurbished)

Issue

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

What you should do

  • Review & post notice, discard affected assembly once replacement received, complete/return reply form.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74209
Background{}
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
AudiencesHealthcare
Source updated2023-08-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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