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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75265

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

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Event summary

Timeline bucket
September 13, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TEM Systems 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

ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

Z-0302-2017
Recall number
Z-0302-2017
Initiated
September 13, 2016
Classification
Class II
Status
Terminated
Recalling firm
TEM Systems Inc
Quantity
637 boxes x 10 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Customers complained of low/empty reagent vials.

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

Customers complained of low/empty reagent vials.

Code information

Lot No. 21929007

Distribution pattern

Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.