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STA® - Liatest® D-Di 00515Recalls & reported problems

Diagnostica Stago · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 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. Feb 5, 2026Open, Classified

    After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

    Z-1585-2026 · Root cause: Process change control · Recall details · FDA record ↗

  2. Sep 12, 2025Open, Classified

    A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

    Z-0205-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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Sources and updates

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