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CEDIA Phenobarbital II Assay
Microgenics Corporation · Model 100003 · UDI-DI 00884883001237
10
510(k) clearances
409
Adverse events
9
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-30 | Siemens Healthcare Diagnostics, Inc. | Imprecision with certain lots |
| 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. |
| 2013-03-14 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals wh |
| 2012-12-10 | Siemens Healthcare Diagnostics, Inc. | Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an applic |
| 2012-11-16 | Abbott Laboratories, Inc | Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The |
| 2012-07-30 | Siemens Healthcare Diagnostics, Inc. | Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, a |
| 2011-06-23 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry P |
| 2009-08-11 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
| 2006-09-26 | Abbott Laboratories Inc. | Erratic elevated results and or the inability to calibrate due to imprecision. |
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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.