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CEDIA Carbamazepine II

Roche Diagnostics GmbH · Model 11815601216 · UDI-DI 04015630994847

LGI Prescription
1
510(k) clearances
0
Adverse events
4
Recalls
4
Facilities

Recalls

DateFirmReason
2007-05-31Abbott Diagnostic International, Ltd.Controls Out of Range/Specification .
2007-05-31Abbott Diagnostic International, Ltd.Controls Out of Range/Specification.
2007-05-31Abbott Diagnostic International, Ltd.Controls Out of Range/Specification .
2007-05-31Abbott Diagnostic International, Ltd.Controls Out of Range/Specification.

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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.