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Recall Observatory FDA recall evidence

Device product

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

February 23, 2017

Class II

Product summary

Firm
Streck
Event
Event 76501
Status
Ongoing
Classification
Class II
Quantity
128,692 tubes
Official record key
device-enforcement:Z-1684-2017

Official wording

Reason: 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.

Derived failure modes

  • 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.