Siemens Dimension Vista Homocysteine Reagent Cartridges Recalled for Leaking
Siemens Healthcare Diagnostics is recalling 583 cartons of Dimension Vista Homocysteine Reagent Cartridges because they are leaking from their wrappers.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging defect (leaking) with no reported injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 583 cartons of Dimension Vista Homocysteine Flex Reagent Cartridges. The recall involves lot numbers 12062MA (expiration 12/01/2012) and 12066MA (expiration 12/05/2012). These in vitro diagnostic test cartridges are used to measure total homocysteine in human serum and plasma.
The recall was initiated because the cartridges are leaking. This leaking is observed when opening the wrapper that holds the reagent cartridge. The affected products were distributed nationwide in the United States, including specific states such as Alabama, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and Wisconsin.
Healthcare facilities and consumers who have these specific lot numbers should stop using the product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 583
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 numbers 12062MA
- exp 12/01/2012
- and 12066MA
- exp 12/05/2012
Distribution
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