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ONLINE TDM Vancomycin Gen.3
Roche Diagnostics GmbH · Model 08058849190 · UDI-DI 07613336121627
LEH
Prescription
1
510(k) clearances
497
Adverse events (1 deaths)
12
Recalls
26
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2019-07-23 | Roche Diagnostics Operations, Inc. | Inaccurately Low Sample Results |
| 2019-07-23 | Roche Diagnostics Operations, Inc. | Inaccurately Low Sample Results |
| 2017-02-21 | Ortho-Clinical Diagnostics | Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on |
| 2016-05-26 | Roche Diagnostics Operations, Inc. | Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due met |
| 2012-07-17 | Siemens Healthcare Diagnostics, Inc. | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VAN |
| 2007-12-20 | Seradyn, Inc. | False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results. |
| 2007-04-30 | Roche Diagnostics Corp. | Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L a |
| 2006-03-30 | Beckman Coulter Inc | Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was a |
| 2005-10-12 | Ortho-Clinical Diagnostics | Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days. |
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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.