Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
Read the official notice →- Date
- 2025-12-03
- Country
- United States
- Brand
- Cepheid
- Product
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Classification
- Class II
- Units
- US Nationwide distribution and Puerto Rico.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Cepheid recalls
- 2025-12-24
US
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
FDA · DeviceCepheidUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI…Official notice →- 2025-11-05
US
Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of…
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
FDA · DeviceCepheidU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice →- 2024-08-21
US
Cepheid recalls Cepheid, Sample Collection Device, Part: 900-0370
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…
FDA · DeviceCepheidWorldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN,…Official notice →- 2023-11-08
US
Cepheid recalls Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
FDA · DeviceCepheidWorldwide distribution - US Nationwide and the countries of Costa Rica,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-10
US
Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis…
Defective Container - A defect in the side-seal which allows leakage of product.
US
Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule…
Failed Stability Specifications: Observed OOS results: eg results for colour index
- 2025-12-04
US
KTEBO Writing Tablet Toys Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by KTEBO
The recalled toys violate the mandatory standard for toys because the screw used to secure the battery compartment that contains a button cell battery does not remain attached as required. When button cell or coin…
- 2025-12-03
US
INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS - InteleConnect / TechPortal
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying…
FDA · DeviceINTELERAD MEDICAL SYSTEMS INCORPORATEDUS Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN,…Official notice →US
DJO, LLC recalls Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures…
FDA · DeviceDJO, LLCUS Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI,…Official notice →US
Mindray DS USA, Inc. dba Mindray North America recalls Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev…
Potential for anesthesia leakage.
FDA · DeviceMindray DS USA, Inc. dba Mindray North AmericaWorldwide - US Nationwide distribution in the states of California, Florida,…Official notice →