Recall Z-1684-2017— Streck
Class II · Ongoing
Class II FDA medical device recall by Streck, initiated 2017-02-23. It names one FDA 510(k) clearance: K080552. 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.. 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..
- Recalling firm
- Streck
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-02-23
- Firm location
- La Vista, NE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.