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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93892

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

Open FDA event record

Event summary

Timeline bucket
January 22, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ortho-Clinical 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

3 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 3

VITROS 3600 Immunodiagnostic System (New and Refurbished)

Z-1220-2024
Recall number
Z-1220-2024
Initiated
January 22, 2024
Classification
Class II
Status
Ongoing
Quantity
489 units (46 US, 443 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Code information

Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

device · product 2 of 3

VITROS 5600 Integrated System (New and Refurbished)

Z-1221-2024
Recall number
Z-1221-2024
Initiated
January 22, 2024
Classification
Class II
Status
Ongoing
Quantity
1460 units (506 US, 954 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Code information

UDI/DI: (New) 10758750002740, (Refurbished) 10758750007110; Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive).

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

device · product 3 of 3

VITROS XT7600 Integrated System

Z-1222-2024
Recall number
Z-1222-2024
Initiated
January 22, 2024
Classification
Class II
Status
Ongoing
Quantity
1,720 units (834 US, 886 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Code information

Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.