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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products VersaTips

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 Class 2 Device Recall VITROS Chemistry Products VersaTipssee related information
Date Initiated by FirmDecember 10, 2021
Create DateMarch 08, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0735-2022
Recall Event ID 89362
Product Classification Micro pipette - Product Code JRC
ProductVITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Code Information UDI 10758750006786  Lot 1039734
FEI Number 1000136573
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactMr. Joe Falvo
585-453-3452
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn December 10, 2021, the firm notified consignees through ORTHO PLUSSM (a service that provides customers with Ortho Clinical Diagnostics product notifications electronically) of the product issue. Customers were instructed to discontinue use and discard the affected lot. Customers should forward the notification if the product was distributed outside of their facility.
Quantity in Commerce4125 units
DistributionDomestic distribution nationwide. Foreign distribution to Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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