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Syva® Emit® 2000 Theophylline Calibrators
Siemens Healthcare Diagnostics Inc. · Model 10445325 · UDI-DI 00842768001031
1
510(k) clearances
9
Adverse events
8
Recalls
22
Facilities
Description
Syva® Emit® 2000 Theophylline Calibrators
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-27 | Siemens Healthcare Diagnostics, Inc. | Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for |
| 2016-06-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophyllin |
| 2016-06-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophyllin |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2012-11-14 | Siemens Healthcare Diagnostics, Inc | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay an |
| 2012-08-09 | Siemens Healthcare Diagnostics, Inc. | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an in |
| 2003-06-18 | Beckman Coulter Inc | Defective software media distributed with upgrade software may cause installation failure and systems lock. |
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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.