Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
FDA Recall Z-0940-2014 · Posted 2014-02-09
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2013-11-06
Date Terminated2015-08-10
Product Quantity3759
Reason for Recall
The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
Firm Action
Siemens sent an Urgent Medical Device Correct letter, dated November 6, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain the recall notification letter with their laboratory records and forward to those who may have received the affected product.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution and USA Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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