Diasorin Recalls LIAISON 1-84 PTH Assay Due to Falsely Elevated Results
Diasorin Inc. is recalling LIAISON 1-84 PTH Assay kits because the system may produce falsely elevated parathyroid hormone results.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves diagnostic error (falsely elevated results) which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Diasorin Inc. is recalling 5,895 units of the LIAISON 1-84 PTH Assay. This in vitro chemiluminescent immunoassay is intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. The recall is due to a potential for the system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
The affected devices are identified by REF 310630 and lot numbers 134909, 134909A, and 134909B. The UDI is 08056771600125. The products were distributed worldwide, including in the United States (KY, OH, GA, PA, FL) and in Canada, Argentina, Bahrain, Bosnia & Herzegovnia, Iraq, Jordan, Morocco, Nepal, Russia, Serbia, Singapore, Taiwan, Thailand, Tunisia, Dubai, Italy, Israel, Brazil, Mexico, Australia, and Bulgaria.
Healthcare facilities and laboratories should stop using the affected lots and contact Diasorin Inc. for instructions on returning or replacing the devices. Patients who have had recent PTH tests using these specific lots should consult their healthcare provider to discuss the potential impact of falsely elevated results on their diagnosis.
The recalled product
- Product
- 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…
- Manufacturer
- Diasorin Inc.
- Hazard
- Affected units
- 5,895
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- REF 310630
- lot numbers: 134909
- 134909A and 134909B
- UDI: 08056771600125
Distribution
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