FDA Medical Device Recalls (openFDA)
Diamedix Corporation: The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
- Recall number
- Z-0541-05
- Recalling firm
- Diamedix Corporation
- Product
- The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
- Status
- Terminated
- Initiated
- 2004-12-23
- Posted
- 2005-02-15
- Terminated
- 2012-05-03
- Reason
- The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.
- Root cause
- Other
- Action
- Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix.
- Quantity
- 178
- Distribution
- Distributed to Domestic customers only.
- Lot, serial or model codes
- Lot # 91803Z and 30804/30804Z
- 510(k) numbers
- ["K970149"]
- PMA numbers
- not on file
- Product code
- LHL
- Firm FEI
- 1044713
- Firm city
- Miami
- Firm state
- FL
- 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