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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87770

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 21, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Siemens Healthcare Diagnostics, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493

Z-1674-2021
Recall number
Z-1674-2021
Initiated
April 21, 2021
Classification
Class II
Status
Ongoing
Quantity
22550 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems

Code information

All Lots

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fed., Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., Ukraine, United Kingdom.