Bayer Healthcare, LLC (Diagnostics Division) Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Brand
Bayer Healthcare, LLC (Diagnostics Division)
Lot Codes / Batch Numbers
Part No. 073-A010, PHNY, GENT and DIG.
Products Sold
Part No. 073-A010; all Advia Chemistry System units are serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
Bayer Healthcare, LLC (Diagnostics Division) is recalling Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine t due to Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.
Recommended Action
Per FDA guidance
Bayer HealthCare LLC issued a Support Bulletin to all affected Bayer HealthCare LLC Branches on/about 2/17/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Customer Bulletins were also issued to the Branches both in the United States and elsewhere for communication with the affected 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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026