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Alinity m

ABBOTT MOLECULAR INC. · Model 09N46-075 · UDI-DI 00884999049598

PAB
0
510(k) clearances
18
Adverse events
1
Recalls
10
Facilities

Description

Alinity m CMV CAL Kit

Recalls

DateFirmReason
2023-09-14Hologic, Inc.Use of assay along with plasma specimen may result in error code which would invalidate sample.

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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.