Ortho-Clinical Recalls Deformed VITROS Chemistry VersaTips
Ortho-Clinical Diagnostics is recalling deformed VITROS Chemistry VersaTips that may cause assay results to be biased by up to +/-16%.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the defect leads to inaccurate test results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 4,062 cartons of VITROS Chemistry Products VersaTips (Lot 413420). The recall involves a total of 4,062,000 tips. These products are used to dispense samples and reagent fluids for various VITROS chemistry assays.
The recall is due to a deformity affecting the specific lot. The use of deformed VersaTips may result in assay results that are biased by up to +/-16% for both immunometric and competitive assays. This inaccuracy could affect the reliability of laboratory test results.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. The tips are compatible with VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, and XT7600 models. Users should check their inventory for Lot 413420 and stop using the affected tips.
The recalled product
- Product
- VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot 413420 Model(s): VITROS 250
- VITROS 350
- VITROS ECi
- VITROS 5
- 1 FS
- VITROS 3600
- VITROS 4600
- VITROS 5600
- VITROS XT7600.
Distribution
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