Aptima® APTIMA URINE SPECIMEN COLLECTION KITRecalls & reported problems
Hologic, Inc. · Aptima® Urine Specimen Collection Kit for Male and Female Urine Specimens, 50 count. · Class 2
All models of Aptima (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 25420045506265), received between Jun 16, 2026 and Jun 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2026Insufficient Device Problem Information
ON (B)(6) 2026, A CUSTOMER IN CANADA CONTACTED HOLOGIC TO REPORT ERGONOMIC CONCERNS ON THEIR OPERATORS. ON (B)(6) 2026, HOLOGIC RECEIVED CLARIFICATION THAT THREE OPERATORS AT THE CUSTOMER SITE SUSTAINED ERGONOMIC INJURIES DUE TO SPECIMEN RACK HANDLING ON THE INSTRUMENT, ADDING AND/OR REMOVING SAMPLE TUBES, AND CAPPING OR UNCAPPING SPECIMEN TUBES. THE INJURIES REPORTED INCLUDED TINGLING AND NUMBNESS IN THE HANDS, PAIN IN THE ELBOW, AND A HAND INJURY. DUE TO THESE INJURIES, THE OPERATORS WERE UNABLE TO PERFORM SOME OF THESE LAB TASKS. THE CUSTOMER REPORTED THE INJURIES INTERNALLY TO THE INJURY NEAR MISS (INM) SHARED HEALTH AND EXTERNALLY TO THE WORKERS¿ COMPENSATION BOARD (WCB). THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS ABOUT THE INJURIES, ANY MEDICAL INTERVENTION OR THE MEDICAL STATUS OF THE INJURED OPERATORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522051 ↗
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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.
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