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Cepheid

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 recall (Z-0959-2026)Cepheid2025-12-18
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 recall (Z-0960-2026)Cepheid2025-12-18
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. recall (Z-0724-2026)Cepheid2025-11-26
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA N recall (Z-0414-2026)Cepheid2025-10-30
Cepheid, Sample Collection Device, Part: 900-0370 recall (Z-2584-2024)Cepheid2024-08-14
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only recall (Z-0215-2024)Cepheid2023-11-02
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, recall (Z-0216-2024)Cepheid2023-11-02
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Micr recall (Z-2431-2015)Cepheid2015-08-20
Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert recall (Z-2432-2015)Cepheid2015-08-20
Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: G recall (Z-0453-2012)Cepheid2012-01-11
Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXper recall (Z-2401-2011)Cepheid2011-05-31
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufacture recall (Z-1898-2010)Cepheid2010-07-01
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicat recall (Z-1651-2010)Cepheid2010-05-25
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indi recall (Z-1652-2010)Cepheid2010-05-25
Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for us recall (Z-0376-2008)Cepheid2008-01-12
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Therm recall (Z-1378-05)Cepheid2005-08-17

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Every clearance here is in the API, with alerts when new ones post.