MAUDE Adverse Event Report: Alere San Diego, Inc. Medline hCG Pregnancy Test Cassette; Visual, Pregnancy Hcg, Prescription Use

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported an unspecified number of false positive results obtained by the customer when testing with the medline hcg pregnancy test cassette.Three attempts were made to obtain additional information, however the customer was unresponsive.No adverse events were reported.
Additional Manufacturer Narrative
B3 - date of event is an estimate as the actual date of occurrence was not provided.Distributor information: (b)(4).H7 and h9 updated to document the recall number provided by fda on 25-sep-2026.Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Retain testing and manufacturing record review could not be performed as a lot number could not be obtained.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined due to insufficient information.Complaints are tracked and trended on a monthly basis.Per the package insert: ¿ very low levels of hcg (less than 50 miu/ml) are present in urine specimens shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.¿ a number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in urine specimens should not be used to diagnose pregnancy unless these conditions have been ruled out.¿ this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: Medline hCG Pregnancy Test Cassette
• Common Device Name: Visual, Pregnancy Hcg, Prescription Use
• Manufacturer (Section D): Alere San Diego, Inc.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; +1(858)805-2506
• MDR Report Key: 50875946
• Report Number: 2027969-2026-00121
• Device Sequence Number: 18820238
• Product Code: JHI
• UDI-Device Identifier: 10888277191877
• UDI-Public: (01)10888277191877
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: k993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FHC-102
• Device Catalogue Number: MPH12025HCG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female