Medline MPH22325HCGRecalls & reported problems
Medline Industries, Inc. · Pregnancy Tests: HCG Combo Pregnancy Test, Cassette, 20 mIU/mL for Urine, 10 mIU/mL for Serum · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20197344024992), received between Sep 8, 2026 and Sep 30, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (7 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952206 ↗MalfunctionSep 23, 2026False Positive Result
It was reported that Urine HCG Kit Box, Lot# HCG24080003U had 2 kits that tested positive. Serum HCG was sent out and resulted negative.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870107 ↗MalfunctionSep 18, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829179 ↗MalfunctionSep 17, 2026False Positive Result
It was reported that "5 total false positives - 4 at Memorial Hospital and 1 at St. Joseph¿s." "All confirmed negative by running serum quant on chemistry analyzer and got BHCG 0."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803952 ↗MalfunctionSep 16, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790132 ↗MalfunctionSep 10, 2026False Positive Result
It was reported that "MULTIPLE FALSE POSITIVE PREGNANCY TEST RESULTS HAVE BEEN REPORTED ACROSS SUTTER SITES USING MEDLINE HCG TEST KIT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720842 ↗MalfunctionSep 8, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675864 ↗
Other Visual, pregnancy hCG, prescription use devices
- McKesson 5001Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls165 reports
- CARDINAL HEALTH B1077-23Cardinal Health 200, LLC · Visual, pregnancy hCG, prescription use1 recall149 reports
- McKesson 5000Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls90 reports
- Sure-Vue 4581405021Fisher Scientific Company L.L.C. · Visual, pregnancy hCG, prescription use1 recall83 reports
- McKesson 5002Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls33 reports
- Henry Schein 9004072Henry Schein, Inc. · Visual, pregnancy hCG, prescription use1 recall79 reports
- AlereTM 92210Alere San Diego, Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls23 reports
- MEDLINE MPH12025HCGMedline Industries, Inc. · Visual, pregnancy hCG, prescription use1 recall69 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page