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FDA Medical Device Recalls (openFDA)

BIOMERIEUX, INC.: VeriCal Calibrator Set

Recall number
Z-0032-06
Recalling firm
BIOMERIEUX, INC.
Product
VeriCal Calibrator Set
Status
Terminated
Initiated
2005-08-19
Posted
2005-10-22
Terminated
2006-10-16
Reason
The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.
Root cause
Other
Action
Consignees were notified on/about 08/31/2005.
Quantity
2334 kits
Distribution
Nationwide
Lot, serial or model codes
Lots 161813, 161907, 161908, 161909
510(k) numbers
not on file
PMA numbers
not on file
Product code
JPA
Firm FEI
3002769706
Firm city
Durham
Firm state
NC
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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