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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products Myoglobin Calibrators

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  Class 2 Device Recall VITROS Immunodiagnostic Products Myoglobin Calibrators see related information
Date Initiated by Firm November 29, 2018
Create Date February 15, 2019
Recall Status1 Terminated 3 on February 06, 2024
Recall Number Z-0844-2019
Recall Event ID 81767
510(K)Number K033300  
Product Classification Calibrator, primary - Product Code JIS
Product Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
Code Information Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date) 
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact Mr. Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
FDA Determined
Cause 2		 Under Investigation by firm
Action On November 29, 2018, the firm sent a customer letter all affected customers. All consignees were notified of the issue and informed of revised instructions for VITROS Myoglobin Calibrators: - Reconstitute the calibrators using 1.0 mL distilled water, as per current instructions. - Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) - Discard reconstituted calibrators after 4 hours. - Acknowledge the information contained in this notification by completing and submitting the Confirmation of Receipt form no later than December 14, 2018. - Post this notification by each VITROS System at your facility that processes this assay or with the user documentation. - Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 4030
Distribution Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.
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 = JIS and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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