Z-0878-2023Class II

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

Name: Z-0878-2023 VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2022-11-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2022-11-17 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma... on 2022-11-17. FDA classified it as Class II and gives the reason as "Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0878-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-17
Posted: 2023-01-04
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: CEW Radioimmunoassay, Parathyroid Hormone
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 root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0878-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0878-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-04

Product code CEW

K101921Class IIVitros Immunodiagnostics Products Intact Pth Reagent Pack, Vitros Immunodiagnostics Products Intact Pth Calibrators, VitOrtho-Clinical Diagnostics / cleared 2010-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)