Z-1684-2017Class II

Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only...

Name: Z-1684-2017 Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only...
Creator: Streck
Published: 2017-02-23
License: https://open.fda.gov/license/

Streck LLC / initiated 2017-02-23 / Open, Classified / root cause: labeling and UDI

FDA source

Streck began a recall of Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box... on 2017-02-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1684-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-02-23
Posted: 2017-03-08
Recalling firm: Streck LLC
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.
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On February 23, 2017, Streck electronically notified customers of the updated device correction. The recalling firm used an electronic mail alert to notify all of their customers the IFU for the recalled product had been revised. The specified the revision included phlebotomy guidelines specific to the 2.0 ml blood collections tubes. The revised IFU was provided as a link in the email. The recalling firm is reportedly able to monitor the access of the revised IFU to ensure each customer has received the information. For further questions, please call (402) 333-1982.
Quantity in commerce: 128,692 tubes
Distribution: 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.
Product codes and lots: UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1684-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1684-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-04-05	2017-03-27

Product code GIM

K080552Class IICyto-Chex BctStreck / cleared 2008-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)