EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
FDA Recall Z-1107-2021 · Posted 2021-02-11
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Recalling FirmPhadia US Inc
Recall StatusTerminated
Product CodeLSW
Date Initiated2020-12-14
Date Terminated2022-08-04
Product Quantity365 kits US
Reason for Recall
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
Firm Action
Phadia US Inc. (Initial Importer/Distributor) issued notification to consignees via phone and FedEx overnight delivery Dec. 17-18 . Letter states reason for recall, health risk and action to take:
Customers are asked to perform the following steps:
1.Scrap EliA dsDNA Well lot BFA3Y/0142 and order a replacement free of charge
2. Assess test results from EliA dsDNA Well lot BFA3Y/0142 and determine if retesting of samples is warranted in accordance with internal operating procedures.
3. Complete the Acknowledgement Form in the Medical Device Field Safety Notice and return the response to the contact person described.
Any questions concerning this issue, contact Phadia US Technical Support at 1-800-346-4364, option #2.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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