Abbott Laboratories, Inc ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
List number 08G98-07 for Conventional Units, List number 04J62-07 for SI Units.
Products Sold
List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.
Abbott Laboratories, Inc is recalling ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00. due to Device has incorrect notation associated with therapeutic drug monitoring assays.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device has incorrect notation associated with therapeutic drug monitoring assays.
Recommended Action
Per FDA guidance
Firm sent device correction letters to consignees on 2/28/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IL, LA, MA, MN, MO, NC, ND, OK, SD, TX
Page updated: Jan 10, 2026