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U.S. Department of Health and Human Services

Class 2 Device Recall Cepheid Sample Collection Device, Part: 9000370

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 Class 2 Device Recall Cepheid Sample Collection Device, Part: 9000370see related information
Date Initiated by FirmJune 20, 2024
Date PostedAugust 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2584-2024
Recall Event ID 94932
510(K)NumberK946283 
Product Classification Culture media, non-propagating transport - Product Code JSM
ProductCepheid, Sample Collection Device, Part: 900-0370
Code Information UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information ContactDarwa Peterson
408-242-7380
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce651,150
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JSM
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