Siemens MicroScan Dried Negative Breakpoint Combo 47 Panels Recalled
Siemens Healthcare Diagnostics is recalling MicroScan Dried Negative Breakpoint Combo 47 panels due to potential false negative or delayed Arginine results.
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: This is a Class II recall involving a potential for inaccurate test results (false negatives/delays) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 683 units of Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099. These panels are used for determining quantitative and/or qualitative antimicrobial agent susceptibility. The affected lot is dated 2013-11-13 with an expiration date of 11/13/2013, and the product was distributed nationwide.
The recall was initiated because the product has the potential for false negative or delayed reaction for Arginine (ARG) results. Additionally, 42-hour identification panel holds may occur due to a weak ARG reaction. This issue could impact the accuracy of antimicrobial susceptibility testing.
Healthcare facilities and laboratories that have received these panels should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 683
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 (2)
- Lot: 2013-11-13
- Exp 11/13/2013.
Distribution
Distributed nationwide across the United States.
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