Streck: 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.

Is my product affected?

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.

• UPC 10844509000836
• UPC 20844509000833

Check against the official notice below — it lists the full affected range.

What happened

Streck issued a recall of its Cyto-Chex BCT 2.0ml blood specimen collection tubes (packaged as 6-tube packs or 100-tube boxes) because the tube stopper can come loose during blood draw when small diameter tube adapters are not used. These adapters help center small diameter tubes so they pierce the stopper correctly in the middle. The recall affected 128,692 tubes distributed worldwide, including throughout the United States and to Belgium, Canada, Germany, Israel, Japan, South Korea, the Netherlands, and the United Kingdom.

The affected tubes are identified by UDI numbers 10844509000836 and 20844509000833, with expiration dates of April 1, 2017, March 16, 2018, and May 25, 2018. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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. Quantity: 128,692 tubes Lot/code info: UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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