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Atellica CH Trf

Siemens Healthcare Diagnostics Inc. · Model 11097613 · UDI-DI 00630414596297

JNM
1
510(k) clearances
1
Adverse events
3
Recalls
3
Facilities

Description

Transferrin (Tnf) - Atellica CH - RGT - 880T

Recalls

DateFirmReason
2021-01-20R & D Systems, Inc.R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low s
2018-11-01R & D Systems, Inc.The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
2016-08-24R & D Systems, Inc.R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine IVD Human sTfR Immunoassay kit were out of the range high. Internal tes

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Data 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.