Device recall: VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Class II FDA enforcement event 90047. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
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, Inc started this device recall on 25 Mar 2022. The firm address in the FDA record is in Raritan, NJ. FDA put the recall in Class II. FDA event 90047 has 3 product records. The first FDA enforcement report date is 25 May 2022. The record gives the status Ongoing.
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: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia…
Recalling firm
Ortho-Clinical Diagnostics, Inc, Raritan, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1112-2022 | VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 | 2502 total: 2154 US; 348 OUS | Class II | Ongoing | 25 May 2022 |
| Z-1113-2022 | VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 | 1575 units total: 1183 US; 392 OUS | Class II | Ongoing | 25 May 2022 |
| Z-1114-2022 | VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793 | 1767 units total: 1521 US; 246 OUS | Class II | Ongoing | 25 May 2022 |
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 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 54
Other events of the firm
Official channels
- FDA enforcement report Z-1112-2022The 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 90047. https://recallregister.com/fda/ii/90047/. 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: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia…
- What quantity of product is in FDA event 90047?
- The event has 3 product records. The first record gives this quantity:
2502 total: 2154 US; 348 OUS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.