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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96937

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

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Event summary

Timeline bucket
May 21, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Diagnostica Stago, 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

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.

Z-1993-2025
Recall number
Z-1993-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Diagnostica Stago, Inc.
Quantity
939 US ( 2,810 total worldwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

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

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

Code information

UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.

Distribution pattern

The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.