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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products Intact PTH Reagent Pack

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  Class 2 Device Recall VITROS Immunodiagnostic Products Intact PTH Reagent Pack see related information
Date Initiated by Firm November 17, 2022
Date Posted January 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-0878-2023
Recall Event ID 91205
510(K)Number K101921  
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
Product VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin)
Catalog Number: 6802892
Code Information UDI-DI: 6802892 (10758750006267) Lot Numbers/Exp Date: 1610 24-Apr-2023; 1621 24-Apr-2023; 1630 08-May-2023; 1640 08-May-2023; 1645 08-May-2023; 1650 29-May-2023; 1670 06-Jun-2023
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact SAME
585-453-3000
Manufacturer Reason
for Recall		 Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
FDA Determined
Cause 2		 Under Investigation by firm
Action Update 12/15/22: Ortho Clinical Issued Further Corrective Action: Resolution To Potential For Negative Bias When Using Vitros¿ Immunodiagnostic Products Intact Pth Reagent Pack. Letter states: Beginning with Lot 1676 (and subsequent lots), VITROS iPTH Reagent Pack has undergone a performance change in the math associated with the internal master calibration to remove the negative bias observed in previous affected lots. This change brings the performance of VITROS iPTH Reagent Pack back to expected levels. The next lot of VITROS Immunodiagnostic Products iPTH Controls to support this change will be Lot 1090. Please note that Lots 1676 and above of iPTH Reagent Pack will only be supported by Lots 1090 and above of VITROS iPTH Controls. Beginning with Lot 1676 (and subsequent lots) of VITROS iPTH Reagent Pack, customers will no longer be required to adjust their laboratory s reference interval when performing patient sample testing. When using VITROS iPTH Reagent Pack intraoperatively, any unaffected lot may once again be used for patient sample testing. To maintain the expected performance of this product, after switching to Lot 1676 (and subsequent lots) customers are advised not to switch back to any of the previous affected lots of VITROS iPTH Reagent Pack. Ortho has also provided new control values for the non-Ortho controls listed beginning on page 2. " Please note that these new control values are available for use with Lots 1676 and above only. " The non-Ortho control values provided in the previous communication (Ref. CL2022-275) are acceptable for use with VITROS iPTH Reagent Pack Lots 1610, 1621, 1630, 1640, 1645, 1650, and 1670. " The original non-Ortho control values, assigned during release, are acceptable for use with Lot 1660 and Lots prior to 1610. " New control lots will be suitable for use with Lot 1676 and above only. The new lots of VITROS iPTH Reagent Pack and VITROS iPTH Controls are available now. To ensure product availability, Ortho has impl
Quantity in Commerce 4,158 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CEW and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
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