DIGIVAL EQ00600XRecalls & reported problems
Alere Scarborough, Inc. · DIGIVAL is a small bench top instrument to be used in conjunction with Abbott™ rapid tests.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811877010623), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Sparking; Sparking
THE CUSTOMER REPORTED THAT THE POWER CORD INSULATION WAS TORN, EXPOSING THE WIRE WITHIN AND THAT THE CORD SPARKED FROM THE DAMAGED AREA OF THE DIGITAL INSTRUMENT POWER CORD ON AN UNKNOWN DATE. AN ABBOTT FIELD SUPPORT REPRESENTATIVE CONFIRMED THAT THERE HAVE BEEN NO HEALTH PROBLEMS OR ANY HARM/INJURY TO THE CUSTOMER AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292076 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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