Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.
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 3/5 (High).
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 involves a medical device where a known chemical interference (acetaminophen metabolite) may compromise test accuracy, posing a risk of harm through potential misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 8,261 units of Dimension Enzymatic Creatinine reagents (Material Number 10471520, UDI Number 00842768030512). The affected lots are FC0324, BB0262, GD0218, GC0184, FB0122, GF1006, FB1050, and EA1102. 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 was initiated because the presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. This interference could potentially affect the accuracy of the creatinine measurements.
The affected units were distributed worldwide and nationwide in the United States, including in numerous states and Puerto Rico. Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - 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
- 8,261
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 #s FC0324
- BB0262
- GD0218
- GC0184
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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