Medical Information Technology Recalls Bi-Directional Communication Analyzer Interface
Medical Information Technology, Inc. is recalling 56 MEDITECH Bi-Directional interactive Communication Analyzer Interface devices due to incorrect transmission of laboratory results.
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 involves a medical device with a defect that could lead to incorrect patient data transmission, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Medical Information Technology, Inc. is recalling 56 units of the MEDITECH Bi-Directional interactive Communication Analyzer Interface. This device integrates with MEDITECH's Laboratory Information System (LIS) and other vendor systems to manage the transfer of patient results and demographic information.
The recall is being issued because the devices may incorrectly transmit laboratory results. The affected software versions include Magic Releases 5.41, 5.52, 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07.
The devices were distributed worldwide, including the United States, Puerto Rico, and Canada. The source text does not specify the exact actions consumers or healthcare facilities should take, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
- Manufacturer
- Medical Information Technology, Inc.
- Hazard
- Affected units
- 56
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)
- Magic Releases 5.41
- 5.52. 5.53
- 5.62
- 5.63
- 5.64 and Client Server Releases 5.64
- 5.65
- 6.05
- 6.06
- 6.07
Distribution
Distributed in 1 state:
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