DIASTAT ANA FANA200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07340058410486), received between Mar 6, 2017 and Feb 22, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K932876); 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 18, 2026.

Recalls naming this device

1. Oct 15, 2015Class IITerminated

   Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.

   Z-0929-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2018Nonstandard Device

  DURING FDA AUDIT OF OUR COMPANY, THE AUDITOR ASSESSED COMPLAINTS (B)(4), AND DEEMED THE ACTIONS IN THE COMPLAINTS TO FALL UNDER 21CFR§806 REPORTS OF CORRECTIONS AND REMOVALS. AN FDA WARNING LETTER (CMS CASE NO. (B)(4)), ISSUED SEPTEMBER 20TH, 2017, TO OUR COMPANY POINTED TO THE REQUIREMENT TO FILE A REPORT OF CORRECTIONS AND REMOVALS RETROSPECTIVELY FOR THE TWO COMPLAINT LOTS. THE REPORTING OF CORRECTIONS AND REMOVALS FOR COMPLAINTS (B)(4) WAS PERFORMED IN SEPT. 2017, RETROSPECTIVELY (9616003-10/09/2017-003-C). ONE MORE COMPLAINT, (B)(4), WAS IDENTIFIED IN JAN. 2018, FOR THE SAME PRODUCT LOTS DURING A REVIEW OF COMPLAINTS FROM 2015-2016 TO ASSESS THE COMPLAINTS FOR MDR AND/OR RECALL REPORTABILITY. AN MDR WAS NOT FILED AT THE TIME OF THE REPORTING OF CORRECTION AND REMOVALS OF THE COMPLAINTS. THE COMPANY HAS SINCE THEN REASSESSED THE COMPLAINTS, AND IS NOW FILING MDRS REGARDING THE TWO COMPLAINT LOTS FANA200 SS 1500 AND FANA200 SS 2009, IN THE THREE COMPLAINTS ((B)(4)). THIS MDR IS REGARDING FANA200 SS 2009. COMPLAINT INVESTIGATION CONCLUDED THAT ALTHOUGH PRODUCT QUALITY REQUIREMENTS STATED IN THE INSTRUCTIONS FOR USE WERE MET AT LOT RELEASE, THE HIGH BACKGROUND IN THE ELISA PLATE,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288167 ↗
• MalfunctionFeb 22, 2018Insufficient Device Problem Information

  DURING FDA AUDIT OF OUR COMPANY, THE AUDITOR ASSESSED COMPLAINTS (B)(4), AND DEEMED THE ACTIONS IN THE COMPLAINTS TO FALL UNDER 21CFR§806 REPORTS OF CORRECTIONS AND REMOVALS. A FDA WARNING LETTER (CMS CASE NO. 524316), ISSUED SEPTEMBER 20TH, 2017, TO OUR COMPANY POINTED TO THE REQUIREMENT TO FILE A REPORT OF CORRECTIONS AND REMOVALS RETROSPECTIVELY FOR THE TWO COMPLAINT LOTS.THE REPORTING OF CORRECTIONS AND REMOVALS FOR COMPLAINTS (B)(4) WAS PERFORMED IN SEPT. 2017, RETROSPECTIVELY (9616003-10/09/2017-003-C). ONE MORE COMPLAINT, (B)(4), WAS IDENTIFIED IN JAN. 2018, FOR THE SAME PRODUCT LOTS DURING A REVIEW OF COMPLAINTS FROM 2015-2016 TO ASSESS THE COMPLAINTS FOR MDR AND/OR RECALL REPORTABILITY. AN MDR WAS NOT FILED AT THE TIME OF THE REPORTING OF CORRECTION AND REMOVALS OF THE COMPLAINTS. THE COMPANY HAS SINCE THEN REASSESSED THE COMPLAINTS, AND IS NOW FILING MDRS REGARDING THE TWO COMPLAINT LOTS FANA200 SS 1500 AND FANA200 SS 2009, IN THE THREE COMPLAINTS ((B)(4)). THIS MDR IS REGARDING FANA200 SS 1500.COMPLAINT INVESTIGATION CONCLUDED THAT ALTHOUGH PRODUCT QUALITY REQUIREMENTS STATED IN THE INSTRUCTIONS FOR USE WERE MET AT LOT RELEASE, THE HIGH BACKGROUND IN THE ELISA PLATE, TH

  Patient problems: No Code Available

  MAUDE report 7288166 ↗
• MalfunctionMay 31, 2017Inadequate Instructions for Healthcare Professional; Nonstandard Device; Expiration Date Error

  FANA200 KIT LOT TS 3577 WAS RE-WORKED DUE TO SHORTENED SHELF-LIFE. THE ALERT STICKER ON THE KIT BOX OF THE LOT INFORMED CUSTOMERS THAT THE SHELF-LIFE HAD BEEN SHORTENED AND REFERENCED A LETTER SENT TO CUSTOMERS FOR MORE INFORMATION, WHERE THE NEW EXPIRATION DATE WAS STATED. THE ORIGINAL KIT BOX LABEL REMAINED ON THE KIT BOX STATING THE ORIGINAL EXPIRATION DATE. THE ALERT STICKER DID NOT HAVE THE NEW EXPIRATION DATE STATED ON IT. IT HAS NOW COME TO EURO DIAGNOSTICA'S ATTENTION THAT IT WOULD HAVE BEEN PREFERABLE TO HAVE HAD THE NEW EXPIRATION DATE STATED ON THE ALERT STICKER. A RECALL OF THE LOT HAS THEREFORE BEEN INITIATED.

  Patient problems: No Information

  MAUDE report 6600314 ↗
• MalfunctionMar 6, 2017Incorrect Or Inadequate Test Results

  THE CUSTOMER, (B)(6), STATED THAT MULTIPLE SAMPLES RESULTING POSITIVE BY THE ANA SCREEN (FANA200, LOT TS 2076) RESULT NEGATIVE DURING THE SECONDARY AUTOANTIBODY SPECIFICITY TESTING. THE CUSTOMER STATED THAT BOTH LEVELS OF CONTROLS RESULTED WITHIN MANUFACTURER RANGE. THE CUSTOMER STATED THAT NO ANA RESULTS WERE REPORTED OUT FROM CUSTOMER. TESTING OF RETAIN MATERIAL AT EURO DIAGNOSTICA WITH A SAMPLE PANEL FORM HEALTHY DONORS SHOWED THAT THERE WAS AN INCREASED RISK FOR EQUIVOCAL SAMPLE RESULTS WITH THE FANA200 LOT TS 2076.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6379820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932876. One submission often covers many models, so check the product and lot details in each record.

• Z-2627-2017 · May 22, 2017 · Terminated
  DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detectio
• Z-0306-2018 · Feb 14, 2017 · Terminated
  Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic dise