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Terminated

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.

FDA Recall Z-2918-2018 · Posted 2018-08-23

Recalling FirmEuro Diagnostica AB
Recall StatusTerminated
Product CodeNHX
Date Initiated2016-02-14
Date Terminated2019-11-05
Product Quantity25 kits (US only)

Reason for Recall

Decreasing performance overtime.

Firm Action

None

Root Cause

Nonconforming Material/Component

Distribution Pattern

Minnesota and Texas Foreign: Iran

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091657IMMUNOSCAN CCPLUSEuro-Diagnostica AB · 2009-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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