Date Initiated by Firm | August 15, 2018 |
Create Date | October 05, 2018 |
Recall Status1 |
Terminated 3 on January 10, 2022 |
Recall Number | Z-0079-2019 |
Recall Event ID |
80959 |
510(K)Number | K081543 |
Product Classification |
Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
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Product | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,
Catalog Number: 6802413 |
Code Information |
Serial Numbers : J56000024 through J56003300 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact | Joe Falvo 585-453-3452 |
Manufacturer Reason for Recall | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. |
FDA Determined Cause 2 | Software design |
Action | ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director. |
Quantity in Commerce | U.S.= 1255 ex-U.S.= 1504 |
Distribution | Nationwide
Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain |
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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510(K) Database | 510(K)s with Product Code = JLW
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