MTS MTS080016Recalls & reported problems
Micro Typing Systems, Inc · MTS Anti-A,B (Murine Monoclonal Blend) Card
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10758750005864), received between May 21, 2024 and May 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 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 Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024False Positive Result; False Positive Result
REPORT 1 OF 2 (B)(4) AND (B)(4), WINDCHILL RA606116 ON 24APR2024 AND 25APR2024, A CUSTOMER CONTACTED ORTHO'S GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE RESULTS OF THE ANTI-A,B WELL WHEN PERFORMING ABO ANTIGEN TESTING OF ONE KNOWN O NEGATIVE DONOR UNIT IN MTS ANTI-A,B (MURINE MONOCLONAL BLEND) GEL CARD LOTS 012023038-01 (EXPIRY 07MAY2024) AND 092223038-01 (EXPIRY30JUL2024) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6)). COMPLAINANT: (B)(6) (LABORATORY TECHNOLOGIST) +1(B)(6); (B)(6) CUSTOMER# (B)(6); (B)(6) MEDICAL CENTER (B)(6), DATE OF EVENTS: 23APR2024 AND 25APR2024, REPORTED BEGINNING 24APR2024. REAGENTS: MTS ANTI-A,B MURINE MONOCLONAL BLEND GEL CARD LOT 012023038-01 (EXPIRY: 07MAY2024, MANUFACTURE: 18AUG2023) MTS ANTI-A,B MURINE MONOCLONAL BLEND GEL CARD LOT 092223038-01 (EXPIRY: 30JUL2024, MANUFACTURE: 29NOV2023) MTS DILUENT 2 PLUS LOT 232 (EXPIRY15SEP2024) ADDITIONAL REAGENTS USED IN TROUBLESHOOTING: MTS A/B MONOCLONAL GEL CARD LOT 081823057-01 (EXPIRY: 21MAY2024) MTS ABD/ABD MONOCLONAL GROUPING GEL CARD LOT 100423053-06 (EXPIRY: 17OCT2024) SAMPLE INFORMATION: 1 DONOR SEGMENT - EXPECTED O POS SAMPLE ID: (B)(6). THE CUSTOMER STATED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19357642 ↗MalfunctionMay 21, 2024False Positive Result; False Positive Result
(B)(4). REPORT 2 OF 2 COMPLAINT DESCRIPTION: ON 24APR2024 AND 25APR2024, A CUSTOMER CONTACTED ORTHO'S GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE RESULTS OF THE ANTI-A,B WELL WHEN PERFORMING ABO ANTIGEN TESTING OF ONE KNOWN O NEGATIVE DONOR UNIT IN MTS ANTI-A,B (MURINE MONOCLONAL BLEND) GEL CARD LOTS 012023038-01 (EXPIRY 07MAY2024) AND 092223038-01 (EXPIRY30JUL2024) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6)). COMPLAINANT: (B)(6) (LABORATORY TECHNOLOGIST) (B)(6); (B)(6) CUSTOMER # (B)(4); (B)(6) MEDICAL CENTER (B)(6). DATE OF EVENTS: 23APR2024 AND 25APR2024, REPORTED BEGINNING 24APR2024. REAGENTS: MTS ANTI-A,B MURINE MONOCLONAL BLEND GEL CARD LOT 012023038-01 (EXPIRY: 07MAY2024, MANUFACTURE: 18AUG2023) MTS ANTI-A,B MURINE MONOCLONAL BLEND GEL CARD LOT 092223038-01 (EXPIRY: 30JUL2024, MANUFACTURE: 29NOV2023) MTS DILUENT 2 PLUS LOT 232 (EXPIRY15SEP2024) ADDITIONAL REAGENTS USED IN TROUBLESHOOTING: MTS A/B MONOCLONAL GEL CARD LOT 081823057-01 (EXPIRY: 21MAY2024) MTS ABD/ABD MONOCLONAL GROUPING GEL CARD LOT 100423053-06 (EXPIRY: 17OCT2024) SAMPLE INFORMATION: 1 DONOR SEGMENT - EXPECTED O POS SAMPLE ID: (B)(6). THE CUSTOMER STATED THAT ON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19357637 ↗
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