AIA-PACK BataHCG Calibrator Set N/ARecalls & reported problems
Tosoh Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560189211353), received between Jul 10, 2020 and Jul 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 18, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN (B)(6) REPORTED THAT THE MEASUREMENT VALUES OF CONTROL (TOSOH MULTI-CONTROL) WERE AROUND OR EXCEED UPPER VALUE OF ASSIGNED RANGE. INTERNAL INVESTIGATION FOUND POOR STABILITY OF THE CALIBRATOR SET. BECAUSE OF THIS, IF THIS CALIBRATOR SET WERE USED AROUND ITS EXPIRATION DATE, TEST RESULTS OF PATIENT SAMPLES AS WELL AS CONTROLS COULD BE 20% HIGHER THAN ORIGINAL VALUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10260684 ↗
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
- McKesson 5002Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls33 reports
- Sure-Vue 4581405021Fisher Scientific Company L.L.C. · Visual, pregnancy hCG, prescription use1 recall83 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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