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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 VersaTips see related information
Date Initiated by Firm January 14, 2021
Create Date February 19, 2021
Recall Status1 Open3, Classified
Recall Number Z-1136-2021
Recall Event ID 87200
Product Classification Enzyme immunoassay, diphenylhydantoin - Product Code DIP
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.
Code Information Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5,1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600. 
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Joe Falvo
585-453-3000
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 4,062 cartons of 1,000 tips (Totaling 4,062,000 tips)
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the country of Canada.
Total Product Life Cycle TPLC 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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