FDA Medical Device Recalls (openFDA)
Phadia US Inc: 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
- Recall number
- Z-1107-2021
- Recalling firm
- Phadia US Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2020-12-14
- Posted
- 2021-02-11
- Terminated
- 2022-08-04
- Reason
- 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).
- Root cause
- Under Investigation by 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.
- Quantity
- 365 kits US
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
- 510(k) numbers
- ["K072393"]
- PMA numbers
- not on file
- Product code
- LSW
- Firm FEI
- 3002807876
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28