Cyto-Chex BCT - blood specimen collection device -… recallZ-1684-2017 · Streck · initiated Feb 23, 2017
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Streck or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-1684-2017
- Status
- Open, Classified
- Initiated by the company
- Feb 23, 2017
- Posted by the FDA
- Mar 8, 2017
- Recalling firm
- Streck
- Quantity
- 128,692 tubes
- Product code
- GIM
- FDA submissions
- K080552
- 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 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.
Code information (models, lots, serial numbers)
UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cyto-Chex BCT 213559Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Cyto-Chex BCT 218980Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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