VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hor

FDA device recall Z-0878-2023 · posted 2023-01-04 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CEW

Quantity affected

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, Japa

Date initiated

2022-11-17

Date posted

2023-01-04

Location

Rochester, NY

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