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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76501

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

Open FDA event record

Event summary

Timeline bucket
February 23, 2017
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Streck

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

Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

Z-1684-2017
Recall number
Z-1684-2017
Initiated
February 23, 2017
Classification
Class II
Status
Ongoing
Recalling firm
Streck
Quantity
128,692 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

Code information

UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018

Distribution pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.