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FDA Medical Device Recalls (openFDA)

Misys Healthcare Systems: Misys Laboratory version 6.1 - Microbiology Module

Recall number
Z-0088-06
Recalling firm
Misys Healthcare Systems
Product
Misys Laboratory version 6.1 - Microbiology Module
Status
Terminated
Initiated
2005-09-29
Posted
2005-10-22
Terminated
2006-02-10
Reason
Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000.
Root cause
Other
Action
Telephone calls and emails dated 9/29/05 to all consignees in production. Product Safety Noticed dated 9/29/2005 was faxed to all consignees testing the product.
Quantity
67
Distribution
Nationwide and Canada, Denmark, Emirates, Saudi Arabia, United Kingdom
Lot, serial or model codes
version 6.1
510(k) numbers
not on file
PMA numbers
not on file
Product code
JQP
Firm FEI
1000306472
Firm city
Tucson
Firm state
AZ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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