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AIA-PACK CA 19-9 Sample Diluting Solution
TOSOH CORPORATION · Model N/A · UDI-DI 04560189211124
10
510(k) clearances
3,190
Adverse events
19
Recalls
21
Facilities
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 Asia Pacific sample |
| 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 Asia Pacific sample |
| 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 Asia Pacific sample |
| 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 Asia Pacific sample |
| 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 Asia Pacific sample |
| 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, which may affect clinic |
| 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: Free T3-REF A13422 |
| 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, depending upon the assay. |
| 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 Use. |
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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.