EliA dsDNA Well - Product Usage: intended for the In-Vitro… recallZ-1107-2021 · Phadia US Inc · initiated Dec 14, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Phadia US Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1107-2021
- Status
- Terminated
- Initiated by the company
- Dec 14, 2020
- Posted by the FDA
- Feb 11, 2021
- Recalling firm
- Phadia US Inc
- Quantity
- 365 kits US
- Product code
- LSW
- FDA submissions
- K072393
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EliA dsDNA Well DECC055000Phadia AB · ANTI-DNA ANTIBODY, ANTIGEN AND CONTROL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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