MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL HEALTH¿ HCG COMBO RAPID TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e" was left blank as the issue was observed in-house by product quality analyst.Investigation conclusion: the customer reported receiving invalid hcg results and blue backgrounds while testing patient samples.During analysis of the reported issues, a failure event was observed which was unrelated to the reported event.The following investigation details covers the investigation findings: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded valid negative results with strong control lines.No invalid results or unclear background issues were observed during in-house testing.The returned used device was visually examined which confirmed the customer's allegation of invalid test result, however this visual examination was well after the read time.Additional retain devices were tested using the customer provided patient samples.The results were read at 3 and 4 minutes and positive results were obtained.A faint blue background was observed to the left of the control line on the retain devices used with the returned patient sample.Additionally, quantitative urine analysis was performed on the returned urine sample.The sample was tested and contained a mean of 2.3 miu/ml.In-house testing did not replicate the reported invalid result issue.As positive results were obtained with the provided patient sample, additional retain testing was performed with 3 and 4miu/ml hcg urine samples.The results were read at 3 and 4 minutes and valid negative results were obtained.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.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.Case details indicate a bluish haze was observed throughout the background of the test strip.In-house testing with the provided patient sample noted a faint blue background on a portion of the test strip just past the control line region.A blue solution is used to treat the test strip during the manufacturing process; it is possible that the presence of urine matrix abnormalities interacting with this solution could result in a bluish haze.Additional testing was performed as a result of the positive hcg results obtained using the provided patient samples.Testing at the higher concentrations of 3 and 4miu/ml yielded valid negative results.Therefore as the issue was only observed with this one sample at a lower concentration, a sample matrix anomaly cannot be ruled out as the cause of the reported issue.Complaints are tracked and trended on a monthly basis.Per the package insert: invalid: control line fails to appear.Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure.Review the procedure and repeat the test with a new test cassette.If the problem persists, discontinue using the test kit immediately and call technical services at (b)(4).
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: CARDINAL HEALTH¿ HCG COMBO RAPID TEST
• 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 ; 8588052506
• MDR Report Key: 24576097
• Report Number: 2027969-2026-00039
• Device Sequence Number: 21121552
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)261222(10)0000955291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: Other
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: 0000955291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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