Recall Z-2584-2024— Cepheid

Name: FDA recall Z-2584-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-20

Class II · Ongoing

Class II FDA medical device recall by Cepheid, initiated 2024-06-20. It names one FDA 510(k) clearance: K946283. Product: Cepheid, Sample Collection Device, Part: 900-0370. Reason: Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results..

Recalling firm: Cepheid
Classification: Class II
Status: Ongoing
Initiated: 2024-06-20
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K946283 — COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMCopan Diagnostics, Inc.·cleared 1995-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cepheid, Sample Collection Device, Part: 900-0370

Reason for recall

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.