FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
- Recall number
- Z-0588-2011
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
- Status
- Terminated
- Initiated
- 2010-03-10
- Posted
- 2010-12-10
- Terminated
- 2011-08-04
- Reason
- Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.
- Root cause
- Other
- Action
- Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.
- Quantity
- 21171
- Distribution
- Nationwide Distribution throughout the US.
- Lot, serial or model codes
- Lot Number: DE0320, FC0306, GB0342, EA0334, FB0278, DA0293, GB0286, FA0355, EA0362, EB0362.
- 510(k) numbers
- ["K952816"]
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- 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