Alinity 08P4030Recalls & reported problems
Abbott GmbH · Alinity c Phosphorus Reagent Kit 8500 test · Class 1
- 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 00380740135133), received between Nov 13, 2023 and Nov 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
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.
MalfunctionNov 13, 2023Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C PHOSPHORUS RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 2.3 - 4.7 MG/DL): (B)(6) INITIAL RESULT 8.2 MG/DL, REPEATED 10.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18121946 ↗
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- Phosphate (Inorganic) ver.2 03183793122Roche Diagnostics GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus11 reports
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- ARCHITECT 7D71-23Abbott GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus2 reports
- Dimension Vista® Flex® reagent cartridge PHOS 10445144Siemens Healthcare Diagnostics Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
- Atellica CH IP 11097611Siemens Healthcare Diagnostics Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.