VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Summary
The FDA issued a Class II for VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales uni by Ortho-Clinical Diagnostics, Inc.. Reason: The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not dete.
Details
Source
Device Recall
External ID
Z-0735-2022
Action Date
2022-03-16
Status
Ongoing
Category
device
Product Description
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Lot/Code Info: UDI 10758750006786 Lot 1039734
Quantity Affected: 4125 units
Reason for Recall
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
Distribution
Domestic distribution nationwide. Foreign distribution to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-10
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0735-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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