Device recall: LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent…
Class II FDA enforcement event 75478. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
DiaSorin is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex).
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
Diasorin Inc. started this device recall on 13 Jul 2016. The firm address in the FDA record is in Stillwater, MN. FDA put the recall in Class II. FDA event 75478 has 1 product record. The first FDA enforcement report date is 30 Nov 2016. The record gives the status Terminated, with the termination date 27 Dec 2017.
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.
USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq,…
Recalling firm
Diasorin Inc., Stillwater, MN.
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-0645-2017 | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and… | 10,739 | Class II | Terminated | 30 Nov 2016 |
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
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Nov 2024 | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens | Device | Class II | 1 |
| 13 Dec 2023 | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 | Device | Class II | 1 |
| 23 Nov 2020 | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative | Device | Class II | 1 |
| 17 Jul 2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Device | Class II | 1 |
| 16 Mar 2015 | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0645-2017The 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 75478. https://recallregister.com/fda/ii/75478/. 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:
USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq,…
- What quantity of product is in FDA event 75478?
- The FDA record gives this quantity:
10,739
- 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.