Home › Siemens Healthcare Diagnostics Inc. › Syva® Emit® 2000 Gentamicin Plus Assay
Syva® Emit® 2000 Gentamicin Plus Assay
Siemens Healthcare Diagnostics Inc. · Model 10445333 · UDI-DI 00842768001086
1
510(k) clearances
67
Adverse events
13
Recalls
21
Facilities
Description
Emit ® 2000 Gentamicin Plus Assay
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-24 | Abbott Gmbh & Co. KG | Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when proce |
| 2018-08-13 | bioMerieux, Inc. | Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level |
| 2018-08-13 | bioMerieux, Inc. | Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level |
| 2018-04-19 | Siemens Healthcare Diagnostics, Inc. | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not sh |
| 2018-04-19 | Siemens Healthcare Diagnostics, Inc. | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not sh |
| 2010-11-30 | Siemens Healthcare Diagnostics, Inc. | False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: ASL, |
| 2009-10-07 | Roche Diagnostics Operations, Inc. | A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient. |
| 2009-10-07 | Roche Diagnostics Operations, Inc. | A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient. |
| 2009-10-07 | Roche Diagnostics Operations, Inc. | A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient. |
| 2009-02-19 | Beckman Coulter Inc. | The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/mL, <3.13 umol/L) with SYNCHRON |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.