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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94495

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

Open FDA event record

Event summary

Timeline bucket
April 23, 2024
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

2 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 2

IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.

Z-1886-2024
Recall number
Z-1886-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Quantity
2,956 units (463 US, 2,493 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

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

The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

Code information

Catalog # L2KTG2, SMN 10381659, UDI/DI: 00630414962108, Lot #s: 782, 783, 786, 787, 788, 789, 791, 792, 793.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Finland, France, Germany, Greece Guatemala, Honduras, Hong Kong, Hungary, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Vietnam.

device · product 2 of 2

IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.

Z-1887-2024
Recall number
Z-1887-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Quantity
488 units (33 US, 455 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.

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

The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.

Code information

Catalog # L2KTG6, SMN 10381655, UDI/DI: 00630414962115, Lot #s: 785, 790, 791, 793.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Finland, France, Germany, Greece Guatemala, Honduras, Hong Kong, Hungary, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Vietnam.