Xpert GBS LB
CEPHEID · Model GXGBS-LB-10 · UDI-DI 07332940000882
NJR
Prescription
1
510(k) clearances
79
Adverse events
11
Recalls
13
Facilities
Description
Xpert GBS LB kit; 10 test kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-07 | Meridian Bioscience Inc | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| 2024-12-19 | Becton Dickinson & Co. | Potential for signal drift in specific lots of BD PCR Cartridges. |
| 2024-12-13 | Hologic, Inc. | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. |
| 2022-03-18 | Hologic, Inc | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially |
| 2015-11-23 | Biomerieux Inc | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. |
| 2013-05-31 | Becton Dickinson & Co. | Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. |
| 2012-12-11 | Becton Dickinson & Co. | Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. |
| 2012-09-18 | Becton Dickinson & Co. | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. |
| 2011-04-01 | Cepheid | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.