FDA Medical Device Recalls (openFDA)
Bayer Healthcare, LLC (Diagnostics Division): ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
- Recall number
- Z-1448-06
- Recalling firm
- Bayer Healthcare, LLC (Diagnostics Division)
- Product
- ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2006-08-29
- Terminated
- 2012-05-24
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K990346"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28