CLASS II Device recall · Reported 29 May 2013 · FDA Enforcement Report
Meditech Bi-Directional interactive Communication Analyzer Interface recalled
Medical Information Technology is recalling Meditech Bi-Directional interactive Communication Analyzer Interface, distributed in Puerto Rico. The recall was initiated on 7 May 2013 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-1365-2013
- FDA event ID
- 65158
- Recalling firm
- Medical Information Technology, Westwood, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2013
- FDA classified
- 22 May 2013
- Reported
- 29 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 7 May 2013 | Recall initiated by company | |
| 22 May 2013 | Classified by FDA | +15 days |
| 29 May 2013 | 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
Incorrect transmission of laboratory results.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
Questions about this recall
Why was it recalled?
Incorrect transmission of laboratory results.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - USA, including Puerto Rico and the country of 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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