Home › Siemens Healthcare Diagnostics Inc. › ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents
ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents
Siemens Healthcare Diagnostics Inc. · Model 10318208 · UDI-DI 00630414517681
10
510(k) clearances
5
Adverse events
4
Recalls
36
Facilities
Description
ASLO - ADVIA Chem. - RGT - 2x100 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-11-18 | Remel, Inc | These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus. |
| 2007-08-08 | BD Diagnostic Systems / Lee Laboratories | Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism. |
| 2006-07-25 | Roche Diagnostics Corp. | The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control res |
| 2003-12-17 | Beckman Coulter Inc | The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5. |
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