Ortho-Clinical Diagnostics, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5, 1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600.
Products Sold
Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5,1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600.
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays a due to A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunom. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 01/18/2021, Ortho Clinical Diagnostics issued an Urgent Product Correction Notification via e-mail due to a a deformity in a specific lot of VITROS Chemistry Products VersaTips. The affected product is to be no longer distributed and discarded.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026