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Synermed®
INFRARED LABORATORY SYSTEMS LLC · Model IR010-1200 · UDI-DI 05060500091682
CIX
Prescription
1
510(k) clearances
113
Adverse events
6
Recalls
37
Facilities
Description
Albumin Reagent 8 X 67 mL
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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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.