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ARCHITECT

Abbott GmbH · Model 06P2237 · UDI-DI 00380740139049

PMT JIT JJX PTF PRI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

ARCHITECT B.R.A.H.M.S PCT Reagent Kit

Recalls

Date	Firm	Reason
2017-12-22	Roche Diagnostics Corporation	Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.

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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.