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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83523

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

Open FDA event record

Event summary

Timeline bucket
July 23, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Instrumentation Laboratory Co.

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

ROTEM ex-tem; US Part No: 503-05-US

Z-2485-2019
Recall number
Z-2485-2019
Initiated
July 23, 2019
Classification
Class II
Status
Terminated
Quantity
364 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Prolonged clotting times

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Prolonged clotting times

Code information

Lot # 42255901 (United States)

Distribution pattern

States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.

device · product 2 of 3

ROTEM ex-tem Canada Part No: 503-05-CA

Z-2486-2019
Recall number
Z-2486-2019
Initiated
July 23, 2019
Classification
Class II
Status
Terminated
Quantity
44 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Prolonged clotting times

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Prolonged clotting times

Code information

Lot # : 42255801 (Canada)

Distribution pattern

States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.

device · product 3 of 3

ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

Z-2487-2019
Recall number
Z-2487-2019
Initiated
July 23, 2019
Classification
Class II
Status
Terminated
Quantity
722 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Prolonged clotting times

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Prolonged clotting times

Code information

Lot # : 42255701

Distribution pattern

States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.