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Hologic devices, product family

by Hologic 11 variants Basic UDI-DI 54200455DIAGCOLLECTVT

Shared by every variant

Manufacturer
Hologic(11)
Basic UDI-DI
54200455DIAGCOLLECTVT
Risk class
Class IIClass AClass I (varies)
Legislation
IVDR
EMDN category
SAMPLES COLLECTION DEVICES - OTHERDEVICES FOR SAMPLES TRANSPORT - OTHER
Market status
11 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 54200455DIAGCOLLECTVT.

Recalls

3 recalls · 1 ongoing · FDA

  • Z-2163-2020 Class II · ongoing · 10 Oct 2019
    Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
  • Z-0595-2018 Class II · terminated · 20 Jan 2018
    The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
  • Z-0027-2018 Class II · terminated · 15 Sep 2017
    An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

Recalls matched to the 11 devices listed on this page; other pages of the family can carry others.

Variants

11 devices · page 1 of 1

Variants of Hologic devices, Basic UDI-DI 54200455DIAGCOLLECTVT
UDI-DISize and differences
Aptima Cervical Specimen Collection and Transport Kit 30265715420045509207 —On the market
Aptima® 301154C / APTIMA LIQUID PAP TRANSFER TUBES, IVD KIT15420045500297 —On the market
Aptima® Aptima Specimen Transfer for Liquid Pap PRD-05110 / Aptima Specimen Transfer for Liquid Pap15420045511880 —On the market
Aptima® APTIMA SWAB SPECIMEN COLLECTION KIT 301041 / APTIMA SWAB SPECIMEN COLLECTION KIT25420045506272 —On the market
Aptima® APTIMA URINE COLLECTION TUBES 105575 / APTIMA URINE COLLECTION TUBES15420045506244 —On the market
Aptima® APTIMA URINE SPECIMEN COLLECTION KIT 301040 / APTIMA URINE SPECIMEN COLLECTION KIT25420045506265 —On the market
Aptima® MULTITEST SWAB COLLECTION KIT, APTIMA, IVD PRD-03546 / MULTITEST SWAB COLLECTION KIT,APTIMA,IVD25420045510187 —On the market
Hologic Direct Load Capture Cap Collection Kits – CLASSIQSwabs PRD-0695125420045514345 —On the market
Hologic Specimen Lysis Tube PRD-0655415420045513709 —On the market
Panther Fusion® SPECIMEN LYSIS TUBES, IVD PRD-04339 / SPECIMEN LYSIS TUBES, IVD15420045509238 —On the market
RespDirect Collection Kit PRD-0740325420045515687 —On the market