ABBOTT 7A12-60Recalls & reported problems
Abbott Laboratories · XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack · Class U
- 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 00380740011635), received between Jun 9, 2017 and Jun 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Test Results1
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.
MalfunctionJun 9, 2017High Test Results; High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED METHOTREXATE RESULTS ON THE TDX ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 9.41 MICROMOL/L, REPEAT 0.55 MMOL/L AND 0.11 AFTER 72 HOURS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6631005 ↗
Other Enzyme immunoassay, methotrexate devices
- ONLINE TDM Methotrexate 09230815190Roche Diagnostics GmbH · Enzyme immunoassay, methotrexate4 reports
- ONLINE TDM Methotrexate 09230785190Roche Diagnostics GmbH · Enzyme immunoassay, methotrexate2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.