Recall Z-1684-2017
Streck · initiated February 23, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-1684-2017
- Initiated
- February 23, 2017
- Posted by FDA
- March 8, 2017
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Quantity
- 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.
- Recalling firm
- Streck, La Vista, NE