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IMMULITE® 2000 Systems SYP Syphilis Screen 10471981Recalls & reported problems

Siemens Healthcare Diagnostics Products Ltd · Syphilis - IMMULITE - RGT - 200 tests · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K091361); they may or may not involve this specific model.

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.

Recalls naming this device

  1. Jul 13, 2026Class IIOpen, Classified

    Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

    Z-2965-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091361. One submission often covers many models, so check the product and lot details in each record.

  • Z-2966-2026 · Jul 13, 2026 · Open, Classified
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

Other ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page