FDA-Device2017-04-05Class II
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.
Streck
Hazard
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.
Sold states
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.
Affected count
128,692 tubes
Manufactured in
7002 S 109th St, La Vista, NE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2017Don't want to check this manually?
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