CLASS II Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
Liaison 1-84 PTH Assay recalled by Diasorin
Diasorin is recalling Liaison 1-84 PTH Assay, distributed nationwide in the US. The recall was initiated on 23 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1342-2021
- FDA event ID
- 87501
- Recalling firm
- Diasorin, Stillwater, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Nov 2020
- FDA classified
- 1 Apr 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Nov 2020 | Recall initiated by company | |
| 1 Apr 2021 | Classified by FDA | +129 days |
| 7 Apr 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Liaison 1-84 PTH Assay recalled?
Yes. Diasorin recalled Liaison 1-84 PTH Assay on 23 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-1342-2021.
Why was it recalled?
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Which lots are affected?
REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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