Phadia US Inc: Medical Device Recall in 2021 - (Recall #: Z-1107-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 14, 2020

Date Posted: February 17, 2021

Recall Number: Z-1107-2021

Event ID: 87161

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).

Status: Terminated

Product Quantity: 365 kits US

Code Information:

Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated