Reported Mar 3, 2021 · Terminated
VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Chemistry
- Products VersaTips - Product Usageused 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
- Lot codes and dates
- Lot 413420 Model(s)
VITROS 250VITROS 350VITROS ECiVITROS 51 FSVITROS 3600VITROS 4600VITROS 5600VITROS XT7600
- Lot 413420 Model(s)
- Amount recalled
- 4,062 cartons of 1,000 tips (Totaling 4,062,000 tips)
Where it was sold
Why it was recalled
A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
This product could cause temporary or reversible health problems — stop using it.
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