FDA Device Intelligence
Home › Hologic, Inc. › Aptima®

Aptima®

Hologic, Inc. · Model CMV, CALIBRATOR KIT, APTIMA, IVD · UDI-DI 15420045514577

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

Description

Aptima® CMV Quant Assay Calibrators Kit.

Recalls

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.