Recall Z-1107-2021— Phadia US Inc

Name: FDA recall Z-1107-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-14

Class II · Terminated

Class II FDA medical device recall by Phadia US Inc, initiated 2020-12-14, terminated 2022-08-04. It names one FDA 510(k) clearance: K072393. 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. 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)..

Recalling firm: Phadia US Inc
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Terminated: 2022-08-04
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01Phadia US, Inc.·cleared 2007-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.