IMMUNOSCAN CCPlus RA-96PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340058410868), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K091657); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2018Device Markings/Labelling Problem

  DURING A RETROSPECTIVE REVIEW, PERFORMED IN JAN 2018, OF COMPLAINTS FILED BY EURO DIAGNOSTICA IN 2015-2016 TO ASSESS THE COMPLAINTS FOR MDR AND/OR RECALL REPORTABILITY, ONE COMPLAINT (B)(4) WAS IDENTIFIED AS REQUIRING REMEDIATION. A MDR IS THEREFORE SUBMITTED TO THE FDA RETROSPECTIVELY FOR THE COMPLAINT. IT CAME TO EURO DIAGNOSTICA'S ATTENTION ON (B)(4) 2016, FROM (B)(4), AN (B)(4) DISTRIBUTOR, THAT AN EURO DIAGNOSTICA PRODUCT END-USER, (B)(6), OBTAINED IMMUNOSCAN CCPLUS KITS WITH FALSIFIED LABELING. ON (B)(4) 2016, EURO DIAGNOSTICA'S QA DEPT. WAS INFORMED OF THE MATTER, AND COULD CONFIRM THAT THE LABELS WERE NOT GENUINE EURO DIAGNOSTICA LABELS. ON THE KIT BOX, TWO LABELS HAD BEEN PLACED: - ONE LABEL, PLACED ON THE SHORT SIDE OF THE KIT BOX, STATED EURO DIAGNOSTICA AS THE MANUFACTURER AND (B)(4) AS IMPORTER, WITH KIT MANUFACTURING DATE (MFD) 2015-04-16. - THE OTHER LABEL, PLACED ON THE LONG SIDE OF THE KIT BOX, WAS VERY SIMILAR TO EURO DIAGNOSTICA'S KIT BOX LABEL FOR IMMUNOSCAN CCPLUS WITH A GENUINE IMMUNOSCAN CCPLUS KIT LOT (SS 1337) AND THE CORRECT EXPIRY DATE (2016-08-18) FOR THAT LOT. THE FALSE LABEL COULD BE RECOGNIZED ON SEVERAL ITEMS, E.G. LACKING SYMBOLS, WRONG SYMBOLS AND

  Patient problems: No Patient Involvement

  MAUDE report 7288168 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091657. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2018 · Feb 14, 2016 · Terminated
  Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CC