Pneumococcus CWPS, 10 mg 3459Recalls & reported problems
Ssi Diagnostica A/S · Cell wall polysaccharide · Class 1
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 05713106034590), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (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.
Most reported problems
Device problems
- Inaccurate Information1
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.
MalfunctionDec 17, 2020Inaccurate Information
DURING PRODUCTION, A NUMBER OF LABELS WITH A WRONG ITEM NUMBER HAVE BEEN PRINTED AND ATTACHED TO THE PRODUCT. THE RELEASE CONTROL DID NOT FIND THIS FEW LABELS, AS THERE IS NOT CURRENTLY A TOTAL CONTROL OF ALL ATTACHED LABELS. IN TOTAL 25 MISLABELS VIALS OUT OF 551 HAVE BEEN IDENTIFIED. PNEUMOCOCCUS CWPS; (B)(6). FDA SAFETY REPORT ID # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11036899 ↗
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- Kreatech FISH probes 40V016V495Leica Biosystems Newcastle Ltd · Reagents, specific, analyte1 recall0 reports
- N/A 346587Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- CytoCell LPS509-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- N/A 340936Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- N/A 347206Becton, Dickinson And Company · Reagents, specific, analyte1 report
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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