Home › Medtest Dx, Inc. › MedTest DX Total Bilirubin for the BS480
MedTest DX Total Bilirubin for the BS480
Medtest Dx, Inc. · Model TIB480 · UDI-DI 00817439021236
CIG
Prescription
10
510(k) clearances
399
Adverse events
19
Recalls
48
Facilities
Description
For the quantitative determination of total bilirubin in serum using the Mindray BS480 analyzer. For in vitro diagnostic use only. 5 x 58ml, 5 x 15ml.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-30 | Siemens Healthcare Diagnostics, Inc. | During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling |
| 2023-08-05 | Ortho-Clinical Diagnostics, INc. | Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate de |
| 2020-07-13 | Ortho-Clinical Diagnostics | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-07-13 | Ortho-Clinical Diagnostics | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2019-09-11 | Roche Diagnostics Operations, Inc. | Due to low Quality Control recovery and invalid Calibration. |
| 2019-08-15 | Beckman Coulter Inc | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quanti |
| 2019-08-15 | Beckman Coulter Inc | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quanti |
| 2018-12-17 | Roche Diagnostics Corporation | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D mod |
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.