Stillwater, MN, United States
Diasorin Inc. recalls
4 recalls recorded since 2018, most recently on 7 November 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 November 2024
- Reason
- Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0677-2025
- DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Ongoing Class II Medical devices
- Recall started
- 13 December 2023
- Reason
- DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0815-2024
- DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Terminated Class II Medical devices
- Recall started
- 23 November 2020
- Terminated
- 6 July 2023
- Reason
- Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
- Distribution
- Worldwide distribution - US Nationwide in the states of KY, OH, GA, PA, FL and the countries of Canada, Argentina, Bahrain, Bosnia & Herzegovnia, Iraq, Jordan, Morocco, Nepal, Russia, Serbia, Singapore, Taiwan, Thailand, Tunisia, Dubai, Italy, Israel, Brazil, Mexico, Australia, and Bulgaria.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1342-2021
- LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathy
Ongoing Class II Medical devices
- Recall started
- 17 July 2020
- Reason
- Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
- Distribution
- NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2936-2020
- Parvovirus B19 IgG EIA kit Part No. V519IGUS
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.