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N Latex ASL
Siemens Healthcare Diagnostics Products GmbH · Model 10445984 · UDI-DI 00842768006807
10
510(k) clearances
5
Adverse events
4
Recalls
36
Facilities
Description
Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
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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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.