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Class 2 Device Recall VITROS Immunodiagnostic Products Myoglobin Calibrators |
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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
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Product Classification |
Calibrator, primary - Product Code JIS
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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
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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
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For Additional Information Contact |
Mr. Joe Falvo 585-453-3452
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Manufacturer Reason for Recall |
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
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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
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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 = JIS and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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