CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report
Vitros Immunodiagnostic Products Intact PTH Reagent Pack recalled
Ortho-clinical Diagnostics is recalling Vitros Immunodiagnostic Products Intact PTH Reagent Pack: UPN 10758750006287, distributed nationwide in the US. The recall was initiated on 5 Oct 2016 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-0903-2017
- FDA event ID
- 75476
- Recalling firm
- Ortho-clinical Diagnostics, Bridgend, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2016
- FDA classified
- 23 Dec 2016
- Reported
- 4 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Oct 2016 | Recall initiated by company | |
| 23 Dec 2016 | Classified by FDA | +79 days |
| 4 Jan 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
Where it was distributed
Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Questions about this recall
Why was it recalled?
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
Which lots are affected?
Lot / Expiry date: 1) 0700 (18 Oct 2016), 0710 (14 Nov 2016), 0748 (16 Feb 2017, 0758 (06 Mar 2017); 2) 0728 (12 Dec 2016), 0738 (02 Jan 2017), 0768 (10 Apr 2017)
Where was it sold?
Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
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 26 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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