FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
- Recall number
- Z-0651-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
- Status
- Terminated
- Initiated
- 2005-02-15
- Posted
- 2005-03-23
- Terminated
- 2005-05-17
- Reason
- The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
- Root cause
- Other
- Action
- Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.
- Quantity
- 1800 kits.
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots 645515, 650134, 655120, 660108.
- 510(k) numbers
- ["K952337"]
- PMA numbers
- not on file
- Product code
- LCP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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