Device recall: VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack…
Class II FDA enforcement event 75476. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
ORTHO-CLINICAL DIAGNOSTICS started this device recall on 5 Oct 2016. The firm address in the FDA record is in Bridgend. FDA put the recall in Class II. FDA event 75476 has 1 product record. The first FDA enforcement report date is 4 Jan 2017. The record gives the status Terminated, with the termination date 19 Jun 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore,…
Recalling firm
ORTHO-CLINICAL DIAGNOSTICS, Bridgend, N/A, United Kingdom.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0903-2017 | 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… | 7,027 Total units | Class II | Terminated | 4 Jan 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 105
Other events of the firm
Official channels
- FDA enforcement report Z-0903-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 75476. https://recallregister.com/fda/ii/75476/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore,…
- What quantity of product is in FDA event 75476?
- The FDA record gives this quantity:
7,027 Total units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.