| Class 3 Device Recall VITROS Immunodiagnostic HBsAg Controls |  |
Date Initiated by Firm | June 22, 2016 |
Create Date | October 25, 2016 |
Recall Status1 |
Terminated 3 on June 11, 2018 |
Recall Number | Z-0313-2017 |
Recall Event ID |
74772 |
510(K)Number | K030067 |
Product Classification |
Kit, serological, positive control - Product Code MJX
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Product | VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598
For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay. |
Code Information |
Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908 Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact | Ortho Technical Solutions Center 800-421-3311 |
Manufacturer Reason for Recall | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm, Ortho Clinical Diagnostics, distributed "Important Product Correction Notification" letters (Ref. CL2016-129) dated 6/22/2016 and Confirmation of Receipts to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only). Foreign affiliates were informed by email (on 22 June 2016) of the issue and instructed to notify their consignees of the issue and required actions. All customers who received the affected product were instructed to immediately discontinue using and discard the affected lots. Forward a copy of the notification if you have provided the affected lot(s) outside of your facility. Post a copy of the notification by each VITROS System that processes VITROS HBsAg Controls and Complete and return the Confirmation of Receipt-Response Required form via fax to: 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM no later 7/1/2016. (Note: If you DO NOT have an alternate lot, it is acceptable to continue using the affected lot(s) following these instructions: 1) Control results must be within acceptable limits on the day of reconstitution (Day 1). 2) Store open-reconstituted vials frozen for up to 4 weeks. The firm recommends that customers aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. 3) Upon receipt of your replacement order, discard all remaining inventory.
Customers with questions please call the Ortho Technical Solutions Center at 1-800-421-3311. |
Quantity in Commerce | 1,621 units |
Distribution | Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland. |
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 = MJX
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