ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
- Recall Initiated
- February 17, 2006
- Posted
- August 29, 2006
- Terminated
- May 24, 2012
- Recall Number
- Z-1448-06
- Quantity
- 1138 for all products
- Firm Location
- Tarrytown, NY
Reason for Recall
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.
Distribution
Worldwide including USA and Puerto Rico.
Lot / Code Info
Part No. 073-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
Root Cause
Other
Action Taken
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.