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.
Read the official notice →- Date
- 2025-11-05
- Country
- United States
- Brand
- Cepheid
- Product
- Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of…
- Classification
- Class II
- Units
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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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 →- 2025-12-03
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Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
- 2024-08-21
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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
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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
- 2025-11-12
- US
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC…
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- US
Teva Pharmaceuticals USA, Inc recalls Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only,…
Subpotent drug; Clavulanate Potassium component
FDA · DrugTeva Pharmaceuticals USA, IncDistributed in three (3) States: MS, OH, CA.Official notice → - 2025-11-05
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Microgenics Corporation recalls Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303,…
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
FDA · DeviceMicrogenics CorporationWorldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI,…Official notice → - US
Trividia Health, Inc. recalls Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
FDA · DeviceTrividia Health, Inc.US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.Official notice → - US
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and…
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters,…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN,…Official notice → - US
MicroSurgical Technology Inc recalls MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
FDA · DeviceMicroSurgical Technology IncUS Nationwide distribution in the state of GA.Official notice →