Recall Z-1136-2021— Ortho-Clinical Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2021-01-14, terminated 2022-12-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-14
- Terminated
- 2022-12-27
- Firm location
- Rochester, NY, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.