Cepheid Cepheid, Sample Collection Device, Part: 900-0370 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cepheid, Sample Collection Device, Part: 900-0370
Brand
Cepheid
Lot Codes / Batch Numbers
UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024, 230535300/ July 14, 2024, 230627500/ August 4, 2024, 231877400/ April 10, 2025
Products Sold
UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025
Cepheid is recalling Cepheid, Sample Collection Device, Part: 900-0370 due to Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 cepheidrecall-24far007@iqvia.com Outside the US phone +44 808 178 5381 Technical Support/Region/Country/Telephone/Email U.S./+1 888 838 3222, option 2/techsupport@cepheid.com; Latin America/N/A/latamsupport@cepheid.com; France/+ 33 563 825 319/support@cepheideurope.com; Germany/+ 49 21 514 474 524/support@cepheideurope.com; Portugal/+ 351 800 913 174/support@cepheideurope.com; Spain/+ 34 919 906 762/support@cepheideurope.com; Other European Countries/+ 33 563 825 319/support@cepheideurope.com; Hong Kong/N/A/techsupportapac@cepheid.com; Middle East and African Countries/+ 971 4 550 8617/support@cepheideurope.com; Other Countries Not Listed/+ 1 408 400 8495/techsupport@cepheid.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026