CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
Meditech Microbiology recalled by Medical Information Technology
Medical Information Technology is recalling Meditech Microbiology, distributed nationwide in the US. The recall was initiated on 21 Feb 2014 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-1234-2014
- FDA event ID
- 67584
- Recalling firm
- Medical Information Technology, Canton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2014
- FDA classified
- 19 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 21 Feb 2014 | Recall initiated by company | |
| 19 Mar 2014 | Classified by FDA | +26 days |
| 26 Mar 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for erroneous result reporting.
Product as listed by the FDA
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
Where it was distributed
Distributed USA (nationwide) and Canada.
Questions about this recall
Why was it recalled?
Potential for erroneous result reporting.
Which lots are affected?
Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.
Where was it sold?
Distributed USA (nationwide) and Canada.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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