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Pointe Scientific, Inc. Albumin
HORIBA INSTRUMENTS INCORPORATED · Model OA902-792 · UDI-DI 00811727014894
CIX
Prescription
1
510(k) clearances
117
Adverse events
6
Recalls
38
Facilities
Description
Pointe Scientific, Inc. Albumin Reagent is for the quantitative determination of Albumin in serum. 12 x 66ml
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-10 | Ortho-Clinical Diagnostics, Inc. | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem |
| 2020-08-27 | Roche Diagnostics Operations, Inc. | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the re |
| 2019-09-11 | Roche Diagnostics Operations, Inc. | Due to low Quality Control recovery and invalid Calibration. |
| 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. |
| 2010-03-10 | Abbott Laboratories Inc. | Observed particulate matter in some reagent cartridges. |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
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