Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential interference in diagnostic assays which could lead to incorrect medical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 23,824 units of Dimension Vista Enzymatic Creatinine test kits (Material Number 10700444, UDI Number 00842768036262). The product is used for the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
The recall is due to the presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, which may cause interference in certain chemistry assays when testing patient samples. This interference could potentially affect the accuracy of the test results.
The affected lots are 20027AC, 19336AA, 19273AA, 19218AB, 19192AB, 19189AA, 19175AA, 20083AA, 20128AB, and 20202AA. The products were distributed worldwide and nationwide in the United States, including in numerous states and Puerto Rico. Healthcare facilities and laboratories should check their inventory for these specific lot numbers and contact Siemens Healthcare Diagnostics for further instructions on handling the recalled product.
The recalled product
- Product
- Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 23,824
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 (7)
- Lot #s 20027AC
- 19336AA
- 19273AA
- 19218AB
- 19192AB
- 19189AA
- 19175AA
Distribution
Part of a larger recall action
This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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