APTIMA

Hologic, Inc. · Model AC2, ROOM TEMP, 250T, READY MADE · UDI-DI 15420045514966

QEP LSL MKZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2024-10-31	Becton Dickinson & Co.	BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2024-10-31	Becton Dickinson & Co.	BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2024-09-12	Abbott Molecular, Inc.	Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit
2023-03-29	Binx Health, Inc.	May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative C

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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.