Vitros® Versatips and Vitros® Microtips
Brand(s)
Summary
Review & post notice, discard affected assembly once replacement received, complete/return reply form.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vitros 3600 Immunodiagnostics System (New & Refurbished) | More than 10 numbers, contact manufacturer. | 680 2914 680 2783 |
| Vitros XT 7600 Integrated System | More than 10 numbers, contact manufacturer. | 684 4461 |
| Vitros 4600 Chemistry System (New & Refurbished) | More than 10 numbers, contact manufacturer. | 6900440 6802445 |
| Vitros 4600 Chemistry System (New & Refurbished) | More than 10 numbers, contact manufacturer. | 6900440 6802445 |
| Vitros 5.1 FS Chemistry System (New & Refurbished) | More than 10 numbers, contact manufacturer. | 6801375 6801890 |
| Vitros XT 3400 Chemistry System | More than 10 numbers, contact manufacturer. | 684 4458 |
| Vitros 5.1 FS Chemistry System (New & Refurbished) | More than 10 numbers, contact manufacturer. | 6801375 6801890 |
| Vitros 5600 Integrated System (New & Refurbished) | More than 10 numbers, contact manufacturer. | 680 2413 680 2915 |
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
Additional information
Details
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
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