Advia 2400 Chemistry System, Automated Clinical Chemistry… recallZ-1450-06 · Bayer Healthcare, LLC (Diagnostics Division) · initiated Feb 17, 2006
Terminated All recalls posted in August 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bayer Healthcare, LLC (Diagnostics Division) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1450-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 17, 2006
- Posted by the FDA
- Aug 29, 2006
- Recalling firm
- Bayer Healthcare, LLC (Diagnostics Division)
- Quantity
- 1138 for all products
- Product code
- JGS
- FDA submissions
- K990346
- Distribution
- Worldwide including USA and Puerto Rico.
Product description
Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under K990346 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA® Chemistry XPT System 10723034Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall174 reports
- ADVIA® 1800 Analyzer 10315183Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE150 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 35880).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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