Recall Z-1448-06 ยท JGS Electrode, Ion Specific, Sodium
Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
| Date | Aug 29, 2006 (initiated Feb 17, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1138 for all products |
| Distribution | Worldwide including USA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |