Medical Information Technology Recalls MEDITECH Microbiology Software Due to Erroneous Results
Medical Information Technology, Inc. is recalling MEDITECH Microbiology software releases 5.6 through 6.14 because of a potential for erroneous result reporting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (erroneous medical results) where specific injury or illness reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medical Information Technology, Inc. is recalling MEDITECH Microbiology software, specifically Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13, and 6.14. The software integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
The recall is being conducted because of a potential for erroneous result reporting. The agency has classified this as a Class II recall. A total of 438 units were distributed nationwide in the United States and in Canada.
Healthcare facilities using these specific versions of the MEDITECH Microbiology software should contact Medical Information Technology, Inc. for further instructions on how to address the potential for erroneous results.
The recalled product
- Product
- 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).
- Manufacturer
- Medical Information Technology, Inc.
- Hazard
- Affected units
- 438
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Client Server Releases 5.6
- 5.65
- 5.66
- 5.67
- 6.0
- 6.05
- 6.07
- 6.1
- 6.13 and 6.14.
Distribution
Distributed nationwide across the United States.
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