Z-1107-2021Class II

EliA dsDNA Well -

Name: Z-1107-2021 EliA dsDNA Well -
Creator: Phadia US Inc
Published: 2020-12-14
License: https://open.fda.gov/license/

Phadia AB / initiated 2020-12-14 / Terminated

FDA source

Phadia US Inc began a recall of 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... on 2020-12-14. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1107-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Posted: 2021-02-11
Terminated: 2022-08-04
Recalling firm: Phadia AB
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
Product code: LSW Anti-Dna Antibody, Antigen And Control
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).
FDA 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 in commerce: 365 kits US
Distribution: US Nationwide distribution.
Product codes and lots: Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1107-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-11

Product code LSW

K072393Class IIElia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01Phadia US, Inc. / cleared 2007-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)