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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89953

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 03, 2022
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

6 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 6

Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots

Z-1020-2022
Recall number
Z-1020-2022
Initiated
March 03, 2022
Classification
Class II
Status
Ongoing
Quantity
2,044 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Code information

All lot numbers UDI: (01)00630414598857(10)53376082(17)20220521 (01)00630414598857(10)53377082(17)20220521 (01)00630414598857(10)70533084(17)20220804

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

device · product 2 of 6

Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

Z-1021-2022
Recall number
Z-1021-2022
Initiated
March 03, 2022
Classification
Class II
Status
Ongoing
Quantity
374 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Code information

All lot numbers UDI: 01)00630414598864(10)10054080(17)20220303 (01)00630414598864(10)10979086(17)20221107 (01)00630414598864(10)53378082(17)20220521 (01)00630414598864(10)70532084(17)20220804

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

device · product 3 of 6

Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots

Z-1022-2022
Recall number
Z-1022-2022
Initiated
March 03, 2022
Classification
Class II
Status
Ongoing
Quantity
230 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Code information

All lot numbers UDI: (01)00630414293639(10)01380084(17)20220804 (01)00630414293639(10)20299080(17)20220303

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

device · product 4 of 6

ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots

Z-1023-2022
Recall number
Z-1023-2022
Initiated
March 03, 2022
Classification
Class II
Status
Ongoing
Quantity
2,315 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Code information

All lot numbers UDI: (01)00630414573342(10)08930076(17)20220115 (01)00630414573342(10)10982085(17)20221108 (01)00630414573342(10)19929072(17)20210819 (01)00630414573342(10)20298079(17)20220304 (01)00630414573342(10)48171081(17)20220304 (01)00630414573342(10)53554081(17)20220521 (01)00630414573342(10)70551083(17)20220805 (01)00630414573342(10)76055076(17)20220115

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

device · product 5 of 6

ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots

Z-1024-2022
Recall number
Z-1024-2022
Initiated
March 03, 2022
Classification
Class II
Status
Ongoing
Quantity
952 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Code information

All lot numbers UDI: (01)00630414574646(10)14530079(17)20220304 (01)00630414574646(10)53553079(17)20220304 (01)00630414574646(10)54118081(17)20220521 (01)00630414574646(10)62860081(17)20220521 (01)00630414574646(10)70552083(17)20220805 (01)00630414574646(10)76807076(17)20220115 (01)00630414574646(10)93281076(17)20220115

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

device · product 6 of 6

ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots

Z-1025-2022
Recall number
Z-1025-2022
Initiated
March 03, 2022
Classification
Class II
Status
Ongoing
Quantity
88 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Code information

All lot numbers UDI: (01)00630414591056(10)13852076(17)20220115 (01)00630414591056(10)46894074(17)20211028 (01)00630414591056(10)89042083(17)20220805

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.