Siemens ADVIA Chemistry Acetaminophen Reagents Recalled for NAC Interference
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Acetaminophen reagents due to a change in N-acetylcysteine concentration that may cause assay interference.
What this means for you
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, and the hazard involves potential assay interference rather than direct physical injury or reported illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Acetaminophen reagents used for in vitro diagnostic testing of acetaminophen in human serum and plasma. The recall involves 1,032 units distributed worldwide, including the United States, Canada, and various European and Middle Eastern countries.
The recall was initiated because a change in the concentration of N-acetylcysteine (NAC) in certain lots may cause interference with the ADVIA Chemistry Systems Acetaminophen assay. This issue affects specific lots with catalog number 07989138 and expiration dates ranging from June 30, 2015, through April 30, 2016.
Healthcare facilities and laboratories should stop using the affected reagents and contact Siemens Healthcare Diagnostics for further instructions. The affected lot numbers are 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, and 47558.
The recalled product
- Product
- ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,032
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 (14)
- Catalog Number 07989138
- Siemens Material Number (SMN) 10327381
- Lot Numbers: 46251
- 46564
- 46369
- 46370
- 46619
- 46782
- 47001
- 47157
- 47558
- with expiration dates June 30
- 2015 through April 30
- 2016.
Distribution
Distributed nationwide across the United States.
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