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FDA Medical Device Recalls (openFDA)

Diasorin Inc.: Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.

Recall number
Z-0703-05
Recalling firm
Diasorin Inc.
Product
Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.
Status
Terminated
Initiated
2004-05-20
Posted
2005-04-13
Terminated
2006-07-22
Reason
When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added.
Root cause
Other
Action
Customers were notified by phone and informed of the problem and recommended users to use only the newer wash program which is identified is a 'W' in front of the program.
Quantity
9
Distribution
CA, FL, NH, PA, SD, TX, WA
Lot, serial or model codes
version 7
510(k) numbers
["K884125"]
PMA numbers
not on file
Product code
JTC
Firm FEI
2182595
Firm city
Stillwater
Firm state
MN
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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