ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
FDA device recall Z-1449-06 · posted 2006-08-29 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare, LLC (Diagnostics Division)
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JGS
- Quantity affected
- 1138 for all products
- Distribution
- Worldwide including USA and Puerto Rico.
- Date initiated
- 2006-02-17
- Date posted
- 2006-08-29
- Date terminated
- 2012-05-24
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |