Abbott Laboratories, Inc The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98, All serial numbers
Products Sold
Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers
Abbott Laboratories, Inc is recalling The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas due to Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
Recommended Action
Per FDA guidance
All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.
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 noticePage updated: Jan 10, 2026