Home › Device types › NIG
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
FDA product code NIG · Class 2 · Immunology
29
Registered devices
3,190
Adverse events
19
Recalls
12
510(k) clearances
Devices with this code
Atellica IM CA 19-9 — Siemens Healthcare Diagnostics Inc.ST AIA-PACK CA 19-9 — TOSOH CORPORATIONAlinity — Abbott GmbHAIA-PACK CA 19-9 Sample Diluting Solution — TOSOH CORPORATIONDimension Vista® Flex® reagent cartridge CA19-9 — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSADVIA Centaur® CA 19-9™ — Siemens Healthcare Diagnostics Inc.CA 19-9 AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.ARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO CLINICAL DIAGNOSTICSAtellica IM CA 19-9 — Siemens Healthcare Diagnostics Inc.Atellica IM CA 19-9 DIL — Siemens Healthcare Diagnostics Inc.Elecsys CA 19-9 — Roche Diagnostics GmbHADVIA Centaur® CA 19-9™ — Siemens Healthcare Diagnostics Inc.Access GI Monitor — Beckman Coulter, Inc.ADVIA Centaur® CA 19-9 MCM — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CA 19-9 DIL — Siemens Healthcare Diagnostics Inc.ST AIA-PACK PROG II — TOSOH CORPORATIONARCHITECT — ABBOTT LABORATORIESADVIA Centaur® CA 19-9™ DIL — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHAtellica IM CA 19-9 — Siemens Healthcare Diagnostics Inc.CA 19-9 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-26 | Siemens Healthcare Diagnostics, Inc. | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the |
| 2024-07-26 | Siemens Healthcare Diagnostics, Inc. | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the |
| 2024-07-26 | Siemens Healthcare Diagnostics, Inc. | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the |
| 2024-07-26 | Siemens Healthcare Diagnostics, Inc. | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the |
| 2024-07-26 | Siemens Healthcare Diagnostics, Inc. | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the |
| 2020-02-07 | Roche Diagnostics Operations, Inc. | The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, whi |
| 2019-04-30 | Beckman Coulter Inc. | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2017-05-09 | Beckman Coulter Inc. | The Access immunoassays are susceptible to biotin interference. |
| 2016-10-19 | Siemens Healthcare Diagnostics, Inc | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for U |
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