CLASS II ONGOING Device recall · Reported 11 Jan 2023 · FDA Enforcement Report
Vitros Immunodiagnostic Products Intact PTH Reagent Pack recalled
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative, distributed nationwide in the US. The recall was initiated on 17 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0878-2023
- FDA event ID
- 91205
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2022
- FDA classified
- 4 Jan 2023
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Nov 2022 | Recall initiated by company | |
| 4 Jan 2023 | Classified by FDA | +48 days |
| 11 Jan 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Vitros Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative recalled?
Yes. Ortho-Clinical Diagnostics recalled Vitros Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative on 17 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0878-2023.
Why was it recalled?
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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