PerkinElmer QSight 210 MD Mass Spectrometer Software Data Overwrite Recall
PerkinElmer is recalling 18 QSight 210 MD mass spectrometers because a software defect may overwrite original data from the last acquired sample when automatic flush is enabled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a software data integrity issue with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
PerkinElmer Health Sciences Canada, Inc. is recalling 18 units of the PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software. The software is intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. The recall is due to a defect where, under certain conditions with the automatic flush enabled, the original data from the last acquired sample may be overwritten.
The affected units were distributed in Florida, Minnesota, and Pennsylvania in the United States, as well as in India, Italy, Korea, and Spain. The recall covers specific serial numbers listed in the agency's documentation. No illnesses, injuries, or deaths have been reported in connection with this recall.
Users of the affected equipment should contact PerkinElmer Health Sciences Canada, Inc. for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
- Manufacturer
- PerkinElmer Health Sciences Canada, Inc.
- Affected units
- 18
Distribution
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