Cepheid, Sample Collection Device, Part: 900-0370

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.

On 6/20/24, "Urgent Medical Device Recall" notices dated 6/18/24 were sent to customers describing the product, problem and actions to taken. The notices informed them of the following: 1) Dispose of Collection/affected Devices from Copan lots you may currently have in use or in your inventory. 2) The quality issue with the Collection Device is intermittent, so the firm asks that if you receive a positive or negative test result, to please follow the Instructions for Use (IFU) for your specific assay, and your facility's protocol related to management of test results. 3) Share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 4) Complete and return the response via email to here: https://iqvia-response.my.site.com/mt/fca?cid=24far007 Firm is investigating the root cause of the reported leaking issue and working with the supplier to avoid recurrence in the future. For recall response support contact the firm at +1 844 920 1427 [email protected] Outside the US phone +44 808 178 5381 Technical Support/Region/Country/Telephone/Email U.S./+1 888 838 3222, option 2/[email protected]; Latin America/N/A/[email protected]; France/+ 33 563 825 319/[email protected]; Germany/+ 49 21 514 474 524/[email protected]; Portugal/+ 351 800 913 174/[email protected]; Spain/+ 34 919 906 762/[email protected]; Other European Countries/+ 33 563 825 319/[email protected]; Hong Kong/N/A/[email protected]; Middle East and African Countries/+ 971 4 550 8617/[email protected]; Other Countries Not Listed/+ 1 408 400 8495/[email protected]