RecallRadar

FDA Device recall Z-0878-2023

VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in huma…

On 2023-01-11 the FDA classified a Class II recall of VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in huma… by Ortho Clinical Diagnostics, citing lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0878-2023
ClassificationClass II
Statusongoing
Initiated2022-11-17
Published2023-01-11
Last updated2026-09-13 11:56 UTC
CompanyOrtho Clinical Diagnostics
DistributionUS

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

Reason

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

Identifiers

code_info
UDI-DI: 6802892 (10758750006267) Lot Numbers/Exp Date: 1610 24-Apr-2023; 1621 24-Apr-2023; 1630 08-May-2023; 1…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2023%22

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