FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions Diagnostics: ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
- Recall number
- Z-1119-2008
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Product
- ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
- Status
- Terminated
- Initiated
- 2008-01-12
- Posted
- 2008-05-06
- Terminated
- 2012-06-20
- Reason
- Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.
- Quantity
- 49,533
- Distribution
- Worldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K971418"]
- PMA numbers
- ["P040018"]
- Product code
- LOL
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- 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