Streck Recalls Cyto-Chex BCT Blood Specimen Collection Tubes
Streck is recalling 128,692 Cyto-Chex BCT blood specimen collection tubes because the 2.0ml tube stoppers may come loose during phlebotomy if small diameter tube adapters are not used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the stopper may come loose, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Streck is recalling 128,692 units of the Cyto-Chex BCT blood specimen collection device, specifically the 2.0ml Immunophenotyping Preservative tubes. The affected products are packaged in 6-tube packs (REF 213559) and 100-tube boxes (REF 218980). The recall covers specific lots with expiration dates of 04-01-2017, 03-16-2018, and 05-25-2018.
The recall was initiated due to complaints that the 2.0ml tube stoppers may come loose during phlebotomy. This issue occurs when small diameter tube adapters, which aid in centering the tubes to properly pierce the stoppers, are not utilized. The affected products were distributed worldwide, including nationwide in the USA and to Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected tubes and contact Streck for further instructions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- 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.
- Manufacturer
- Streck
- Hazard
- Affected units
- 128,692
Distribution
Distributed nationwide across the United States.
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