Data Foundry

Medical device recalls 2017

Cyto-Chex BCT — Class II medical device recall Z-1684-2017

Ongoing recall by Streck, reported 2017-04-05, distributed nationwide. Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not

Recall numberZ-1684-2017
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStreck, La Vista, NE, United States
Recall initiated2017-02-23
Classified2017-03-27
Reported by FDA2017-04-05
DistributedNationwide (US)
Countries outside the USBE, CA, DE, GB, IL, JP, KR, NL
Quantity128,692 tubes
UPC / GTIN / UDI-DI10844509000836, 20844509000833
Lot numbers50910309, 60760309, 61460309
Model numbers100-TUBE, 213559, 218980

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1684-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.