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Atellica CH hsCRP

Siemens Healthcare Diagnostics Inc. · Model 11097633 · UDI-DI 00630414596174

NQD
1
510(k) clearances
18
Adverse events
3
Recalls
22
Facilities

Description

High Sensitivity C-Reactive Protein (hsCRP) Atellica CH - RGT 740T

Recalls

DateFirmReason
2016-02-26Roche Diagnostics Operations, Inc.Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5
2015-11-11Siemens Healthcare Diagnostics IncStratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
2015-11-11Siemens Healthcare Diagnostics IncStratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

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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.