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ACB-IT  January 2004

ACB-IT January 2004

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Subject:

Re: FDA Press Release about MiSys LIS

From:

Rick Jones <[log in to unmask]>

Reply-To:

IT working group of the Association of Clinical Biochemists <[log in to unmask]>

Date:

Sun, 18 Jan 2004 15:23:58 +0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (57 lines)

We keep our options open and our systems complex!

Histopath moves in mysterious ways.

R

>>> [log in to unmask] 01/14/04 03:30pm >>>
... I thought you had just signed an all-iSoft contract...?

J


On Friday, Jan 9, 2004, at 15:52 Europe/London, Rick Jones wrote:

> Yes - we had seen this especially since we are just installing a Mysis
> Histopath system.
>
> Rick
>
>
>
>>>> [log in to unmask] 01/09/04 09:42am >>>
> Read the 2003 MedWatch safety summary, including a link to the FDA/CDRH
> recall notice, at:
>
> http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#misys 
>
>
> Misys Healthcare Issues Domestic and International Recall of Misys
> Laboratory, a Laboratory Information System Software Device
> This is a revised version of FDA Press Release P03-79, issued on Oct.
> 10,
> 2003.
> Corrections were made to the original version, which is now obsolete.
> Misys Healthcare Systems of Tucson, Ariz., is initiating a domestic and
> international recall of the Misys Laboratory software versions 5.2,
> 5.23 and
> 5.3. In some instances, these particular versions of this software have
> demonstrated a defect that could result in quality assurance filters
> and
> flags not being included in the patient report used for the diagnosis
> and/or
> treatment of a patient.
> To date no injuries have been reported in connection with this problem.
> FDA
> has been made aware of the recall and is working with the company.
> The recalled products have been distributed to health care facilities
> throughout the world. Misys Healthcare Systems is notifying its
> customers
> and strongly advising that the health care institutions using this
> product
> request the individual code correction package B-AUT-RAPID-LAB as soon
> as
> possible.
> Such requests should be made to the Misys Client Advocate at
> 1-877-239-6337.
> European clients may call 44 (0) 161 335 0562.

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