Kit, Dna Detection, Human Papillomavirus

Reports per year

Source: FDA adverse event reports by year received, 2003–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-12-01Open, ClassifiedNo Marketing Application

  HPV Antigen Test

  Distribution without premarket approval/clearance.

• 2025-07-23Open, ClassifiedUnder Investigation by firm

  BD COR System Software. Model Number: 444829.

  Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

• 2024-12-03Open, ClassifiedSoftware design

  BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988

  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 service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

• 2024-10-29Open, ClassifiedDevice Design

  Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091

  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. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

• 2018-09-14TerminatedUnder Investigation by firm

  INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.

  Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

• 2013-09-10TerminatedDevice Design

  KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas HPV Test include the following liquid based collection media and collection device: " ThinPrep Pap TestTM PreservCyt Solution " Endocervical Brush/Spatula

  During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas 4800 HPV Master Mix reagent that was packaged in four (4) cobas 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina

• 2003-11-19TerminatedOther

  Coulter DNA Prep Reagents Kit Part 6607055

  Labeling Error-Omission of 'Research Use Only'

• 2003-03-19TerminatedOther

  Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096

  In Vitro diagnostic test kit may produce false positive patient results

• 2003-03-19TerminatedOther

  Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.

  In Vitro diagnostic test kit may produce false positive patient results

• 2003-03-19TerminatedOther

  Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296

  In Vitro diagnostic test kit may produce false positive patient results