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Terminated

ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

FDA Recall Z-1448-06 · Posted 2006-08-29

Recalling FirmBayer Healthcare, LLC (Diagnostics Division)
Recall StatusTerminated
Product CodeJGS
Date Initiated2006-02-17
Date Terminated2012-05-24
Product Quantity1138 for all products

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide including USA and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990346BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp. · 1999-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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