CLASS II ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
Meditech Expanse Laboratory (LAB), Microbiology (MIC) recalled
Medical Information Technology is recalling Meditech Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), distributed nationwide in the US. The recall was initiated on 5 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2569-2025
- FDA event ID
- 97455
- Recalling firm
- Medical Information Technology, Canton, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Feb 2025
- FDA classified
- 16 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Feb 2025 | Recall initiated by company | |
| 16 Sep 2025 | Classified by FDA | +223 days |
| 24 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Product as listed by the FDA
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
Questions about this recall
Why was it recalled?
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Which lots are affected?
Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medical Information Technology
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Meditech Microbiology recalled by Medical Information Technology | Medical Information Technology | Other | Nationwide |
| Device | CLASS II | Meditech Microbiology - Calculator/data processing module recalled | Medical Information Technology | Other | Nationwide |
| Device | CLASS II | Meditech Bi-Directional interactive Communication Analyzer Interface recalled | Medical Information Technology | Other | PR |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |