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Recall Observatory FDA recall evidence

Device product

Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

Z-1076-2014

January 06, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 67235
Status
Terminated
Classification
Class II
Quantity
3496
Official record key
device-enforcement:Z-1076-2014

Official wording

Reason: Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).

Code information: lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).