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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 350 Chemistry System,

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  Class 2 Device Recall VITROS 350 Chemistry System, see related information
Date Initiated by Firm April 08, 2019
Create Date July 03, 2019
Recall Status1 Terminated 3 on November 12, 2020
Recall Number Z-1936-2019
Recall Event ID 82784
510(K)Number K922072  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS 350 Chemistry System, Product Code
6802153, (UDI # 10758750002054)

Product Usage:
Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Code Information All lots
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		 Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
FDA Determined
Cause 2		 Device Design
Action On 08 April 2019, a customer letter (Ref. CL2019-090) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) to either all customers who were shipped affected VITROS 250 or 350 Systems. This communication provided the following required actions: - As per the VITROS CK Slide Instructions for Use, perform Quality Control (QC) testing daily to help ensure the slides are performing within acceptable limits. - If QC results are outside of the established ranges, discard the cartridge and repeat QC testing using a fresh cartridge of VITROS CK Slides. - If multiple cartridges are loaded on the VITROS 250/350 System, daily QC testing must be performed for each cartridge prior to use. - Consider loading one cartridge of VITROS CK Slides on board your system at a time. - Complete and return the request form via fax to 1-888-557-3759. Foreign affiliates were informed by email on 08 April 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take.
Quantity in Commerce 3889 units
Distribution US Nationwide Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = EASTMAN KODAK COMPANY
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