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Siemens Healthcare Diagnostics, Inc. alerts

Verified recalls, refunds, lawsuits, and settlements involving Siemens Healthcare Diagnostics, Inc..

Recall Active FDA Official source

Siemens Healthcare Diagnostics, Inc.: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN...

out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health...

Company: Siemens Healthcare Diagnostics, Inc.
Deadline: No deadline listed
Source: U.S. Food and Drug Administration

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Recall Active FDA Official source

Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic Recall

Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic...

Company: Siemens Healthcare Diagnostics, Inc.
Deadline: No deadline listed
Source: U.S. Food and Drug Administration

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Recall Active FDA Official source

Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536....

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient...

Company: Siemens Healthcare Diagnostics, Inc.
Deadline: No deadline listed
Source: U.S. Food and Drug Administration

View affected products Official source