| Class 2 Device Recall VITROS Chemistry Products VersaTips | |
Date Initiated by Firm | January 14, 2021 |
Create Date | February 19, 2021 |
Recall Status1 |
Terminated 3 on December 27, 2022 |
Recall Number | Z-1136-2021 |
Recall Event ID |
87200 |
Product Classification |
Enzyme immunoassay, diphenylhydantoin - Product Code DIP
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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
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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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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