Recall record at a glance
| Official record | Z-1342-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Diasorin Inc. |
| Report date | Apr 7, 2021 |
| Recall initiation date | Nov 23, 2020 |
| Quantity | 5,895 devices |
| Location | Stillwater, MN, United States |
Official product description
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 parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON Analyzer family.
Why the product was recalled
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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