Cepheid: Cepheid, Sample Collection Device, Part: 900-0370

Recall number

Z-2584-2024

Recalling firm

Cepheid

Product

Cepheid, Sample Collection Device, Part: 900-0370

Status

Open, Classified

Initiated

2024-06-20

Posted

2024-08-14

Terminated

not on file

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.

Root cause

Under Investigation by firm

Action

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

Quantity

651,150

Distribution

Worldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN, KY, NH, WI, MO, NC, UT, WA, FL, NJ, SC, CO, PA, SD, NE, MT, WV, GA, MA, RI, CT, DE, MS, OK, VA, ID, AZ, OR, MI, IN, TN, AL, KS, ME, AR, NV, HI, AK, NM, WY, VT, ND, DC OUS (foreign) to countries of: Chile, Ireland, Oman, Nicaragua, Germany, San Marino, Ecuador, New Caledonia, France, Austria, United Kingdom, Finland, Italy, Hong Kong, Kuwait, United Arab Emirates, Netherlands, Belgium, Monaco, Colombia, Spain, Portugal, Poland, Switzerland, Denmark, Jersey, Mexico

Lot, serial or model codes

UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025

510(k) numbers

["K946283"]

PMA numbers

not on file

Product code

JSM

Firm FEI

3004530258

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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