Recall Z-2918-2018— Euro Diagnostica AB

Name: FDA recall Z-2918-2018
Creator: U.S. Food and Drug Administration
Published: 2016-02-14

Class II · Terminated

Class II FDA medical device recall by Euro Diagnostica AB, initiated 2016-02-14, terminated 2019-11-05. It names one FDA 510(k) clearance: K091657. Product: Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.. Reason: Decreasing performance overtime..

Recalling firm: Euro Diagnostica AB
Classification: Class II
Status: Terminated
Initiated: 2016-02-14
Terminated: 2019-11-05
Firm location: Malmo, Sweden

510(k) clearances named in this recall

1 on FDA's record

K091657 — IMMUNOSCAN CCPLUSEuro-Diagnostica AB·cleared 2009-11-19

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

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

Reason for recall

Decreasing performance overtime.

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