Siemens Microscan Plus Negative Combo 3 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a score of 5 (Critical).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 57,600 Microscan plus Negative Combo 3 panels. The recall is due to a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and/or meropenum. These panels are used with the Walk Away System to determine antimicrobial agent susceptibility and identification for gram-negative bacteria.
The affected product, identified by Internal Number B1016-201 and Catalog Number 10444600, was distributed worldwide. In the United States, the product was sold in Alaska, South Carolina, Iowa, Missouri, Georgia, Wisconsin, Texas, Kansas, California, Illinois, Colorado, Arizona, South Dakota, Indiana, Maryland, Florida, and Minnesota. The product was also distributed in numerous countries including Japan, France, Germany, and the United Kingdom.
This recall is classified as Class I by the FDA. Users should stop using the affected panels and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 57,600
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)
- Internal Number - B1016-201
- Catalog Number - 10444600
Distribution
Part of a larger recall action
This product is one of 11 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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