Verigene® Processor SP (Refurbished) 10-0000-07RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840487101490), received between Jun 8, 2022 and Aug 4, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 reports).

3 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 18, 2021Open, Classified

   Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

   Z-1488-2021 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 15, 2020Terminated

   An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

   Z-2776-2020 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 15, 2020Terminated

   An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

   Z-2775-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Failure of Device to Self-Test

  THE SERVICE VISIT AT BLANCHARD VALLEY HEALTH SYSTEM WAS SCHEDULED AFTER THE CUSTOMER REPORTED NO CALLS USING THE BC-GP AND BC-GN ASSAY WITHIN WORK ORDER WO-00199347. DURING THE SITE VISIT, THE AMPLIFICATION (AMP) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 3. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTIONS 7 AND 8 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170120 ↗
• MalfunctionAug 4, 2022Output Problem

  THE SERVICE VISIT AT RUTLAND REGIONAL MEDICAL CENTER WAS SCHEDULED AFTER THE CUSTOMER REPORTED REPEATED NO-CALL INTERNAL CONTROL FAILURES ON THE EP ASSAY WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTIONS 7 AND 8 WERE UPDATED TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15170099 ↗
• MalfunctionAug 4, 2022Failure of Device to Self-Test

  THE SERVICE VISIT AT HC SYSTEMS LLC WAS SCHEDULED ACTION-21-014 WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTIONS 7 AND 8 WERE UPDATED TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170049 ↗
• MalfunctionJun 13, 2022Output Problem

  A PM VISIT AT (B)(6) MEDICAL CENTER (B)(6) WAS SCHEDULED WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT ((B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 14682027 ↗
• MalfunctionJun 13, 2022Output Problem

  THE SERVICE VISIT AT THE (B)(6) HOSPITAL WAS SCHEDULED PER CAPA-(B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838).

  Patient problems: Insufficient Information

  MAUDE report 14681962 ↗
• MalfunctionJun 8, 2022Output Problem

  THE SERVICE VISIT AT TALLAHASSEE MEMORIAL HOSPITAL WAS SCHEDULED PER (B)(4) WITHIN WORK ORDER WO-00200320. DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838).

  Patient problems: Insufficient Information

  MAUDE report 14637995 ↗