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U.S. Department of Health and Human Services

Class 2 Device Recall LIAISON 184 PTH Assay

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 Class 2 Device Recall LIAISON 184 PTH Assaysee related information
Date Initiated by FirmNovember 23, 2020
Create DateApril 01, 2021
Recall Status1 Terminated 3 on July 06, 2023
Recall NumberZ-1342-2021
Recall Event ID 87501
510(K)NumberK150879 
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
ProductLIAISON 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.
Code Information REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Recalling Firm/
Manufacturer
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
FDA Determined
Cause 2
Under Investigation by firm
ActionA Recall notification letter titled, "Urgent DIASORIN CUSTOMER NOTIFICATION LETTER" was sent to consignees on 11/23/2020 via email. The letter instructs the consignee to stop using the LIAISON 1-84 PTH Assay (REF 310630) lot numbers 134909, 134909A, 134909B, and destroy any remaining inventory. They are asked to please complete the bottom portion of the letter and return to DiaSorin to obtain replacement product. The consignee is also instructed to forward the letter to anyone who may be impacted at their facility or anyone these kits have been distributed to outside of the consignee's organization.
Quantity in Commerce5,895 devices
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CEW
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