Streck recalls Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6…

Recall date

February 23, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1684-2017

FDA classification

Class II

Brand / firm

Streck

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.