RecallRadar

FDA Device recall Z-2720-2014

Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081

On 2014-10-08 the FDA classified a Class II recall of Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081 by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension V….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2720-2014
ClassificationClass II
Statusterminated
Initiated2014-08-18
Published2014-10-08
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System.

Reason

Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.

Identifiers

code_infolot 3GM081, exp. 07-01-2014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2720-2014%22

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