| Class 2 Device Recall LIAISON 184 PTH Assay |  |
Date Initiated by Firm | November 23, 2020 |
Create Date | April 01, 2021 |
Recall Status1 |
Terminated 3 on July 06, 2023 |
Recall Number | Z-1342-2021 |
Recall Event ID |
87501 |
510(K)Number | K150879 |
Product Classification |
Radioimmunoassay, parathyroid hormone - Product Code CEW
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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 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
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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 |
Action | A 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 Commerce | 5,895 devices |
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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = CEW
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