FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
- Recall number
- Z-0028-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
- Status
- Terminated
- Initiated
- 2003-09-02
- Posted
- 2003-10-15
- Terminated
- 2003-12-10
- Reason
- Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
- Root cause
- Other
- Action
- Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.
- Quantity
- 21958
- Distribution
- United States, Canada and Germany
- Lot, serial or model codes
- All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNN
- 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