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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

Agency Publication Date: June 5, 2020
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Affected Products

Product: ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.

Lot # 501874

Lot Numbers:
501874
Product: Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.

Lot # 291011 ***Added 9/9/20*** 201115

Lot Numbers:
291011
Product: ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

Lot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374

Product: Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

Lot #s 100051, 100025, 100002, 190294, 190256, 190200, 190171, 190135, 190126 ***Added 9/9/20*** 100087 ***Added 11/2/20*** 100109 100136 100167 ***Added 3/11/21*** 110032

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.

Lot #s FC0324, BB0262, GD0218, GC0184, FB0122 ***Updated 8/4/20*** GF1006 ***Added 9/10/20*** FB1050 ***Added 11/2/20*** EA1102

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.

Lot #s 20027AC, 19336AA, 19273AA, 19218AB, 19192AB, 19189AA, 19175AA, ***Updated 8/4/20*** 20083AA ***Updated 11/2/20*** 20128AB 20202AA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85602
Status: Resolved
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 6 products (5; 26; 1006; 1488; 8261; 23,824)
Agency Last Updated: March 11, 2021

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.