Siemens Dimension Vista Enzyme 1 Calibrator Recalled for QC Shifts
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Enzyme 1 Calibrator due to quality control shifts and imprecision during Pseudocholinesterase calibration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes performance issues (QC shifts and imprecision) without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,496 units of Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL), specifically lots 3FD034 and 3HD012. These products are in vitro diagnostic multi-analyte calibrators used for the calibration of Amylase, Gamma-Glutamyl Transferase, Lactate Dehydrogenase, Lipase, and Pseudocholinesterase methods on the Dimension Vista System.
The recall was initiated after complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration. The affected lots have expiration dates of 6/17/2014 and 9/1/2014, respectively.
The product was distributed nationwide. Users of the Dimension Vista System should check their inventory for these specific lot numbers and stop using the affected calibrators. Siemens Healthcare Diagnostics, Inc. is the recalling firm.
The recalled product
- 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 o
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,496
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- lot 3FD034
- exp. 6/17/2014
- and lot 3HD012
- exp. 9/1/2014.
Distribution
Distributed nationwide across the United States.
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