10 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 2019
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 2019
Cepheid, Sample Collection Device, Part: 900-0370
FDA Enforcement
Class II
·Ongoing·Cepheid·August 21, 2024
Cepheid Xpert C. difficile/Epi Control Panel
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·June 26, 2019
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Enforcement
Class II
·Ongoing·Cepheid·December 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Enforcement
Class II
·Ongoing·Cepheid·December 24, 2025
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
FDA Enforcement
Class II
·Ongoing·Cepheid·December 3, 2025
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
FDA Enforcement
Class II
·Ongoing·Cepheid·November 8, 2023
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
FDA Enforcement
Class II
·Ongoing·Cepheid·November 8, 2023
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
FDA Enforcement
Class II
·Ongoing·Cepheid·November 5, 2025