N LATEX FLC lambda 10873630Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Quantitative determination of free light chains (FLC) type lambda in human serum and EDTA-plasma on Siemens analyzers · Class 2
Data updated Oct 16, 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 00630414167664), received between Apr 9, 2026 and Apr 9, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionApr 9, 2026Low Test Results
THE CUSTOMER REPORTED A FALSELY DEPRESSED N LATEX FLC LAMBDA RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A ATELLICA CH 930 INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) . THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED N LATEX FLC LAMBDA RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825322 ↗
Other LAMBDA, ANTIGEN, ANTISERUM, CONTROL devices
- Freelite® Human Lambda Free Kit for use on the SPAPLUS LK018.SThe Binding Site Group Limited · Lambda, Antigen, Antiserum, Control1 recall2 reports
- Freelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk Kit LK018.10SThe Binding Site Group Limited · Lambda, Antigen, Antiserum, Control1 recall0 reports
- Optilite Freelite Lambda Kit LK018.OPT.AThe Binding Site Group Limited · Lambda, Antigen, Antiserum, Control2 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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