Roche Diagnostics Gmbh
SANDHOFER STRASSE 116, MANNHEIM Baden-Wurttemberg, DE
Registered product codes
272 product codes
Recent MDR events
160 on file
- COBAS PROJul 6, 2026InjuryMW5190327
- IONIFY STEROIDS 1Apr 1, 2026Malfunction1823260-2026-01219
- BETA HCGFeb 9, 2026InjuryMW5183534
- BETA HCGFeb 9, 2026InjuryMW5183535
- BETA HCGFeb 9, 2026InjuryMW5183536
- BETA HCGFeb 9, 2026InjuryMW5183537
- BETA HCGFeb 9, 2026InjuryMW5183548
- BETA HCGFeb 9, 2026InjuryMW5183549
- BETA HCGFeb 9, 2026InjuryMW5183550
- BETA HCGFeb 9, 2026InjuryMW5183551
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002806559.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
7 on file
Top refusal reasons
Compare to industry ↗- Division of West Coast Imports (DWCI)Apr 20, 2026
75PDA \ INVESTIGATIONAL USE ONLY - CLINICAL CHEMISTRY
- Division of Southeast Imports (DSEI)Dec 18, 2025
81PCZ \ INVESTIGATIONAL USE ONLY - IMMUNOLOGY
- Division of Southeast Imports (DSEI)Dec 18, 2025
81PCZ \ INVESTIGATIONAL USE ONLY - IMMUNOLOGY
- Division of Southeast Imports (DSEI)May 2, 2025
79FMK \ SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
- Division of Southeast Imports (DSEI)May 2, 2025
79FMK \ SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
- Division of West Coast Imports (DWCI)Aug 8, 2024
75PDA \ INVESTIGATIONAL USE ONLY - CLINICAL CHEMISTRY
- Division of Southeast Imports (DSEI)May 17, 2024
75NBW \ SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER