Siemens MicroscanrapID/S panels recalled for antimicrobial misreads
Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
What this means for you
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 with a confirmed defect that leads to inaccurate diagnostic results (false susceptible/intermediate reads). This poses a risk of inappropriate antibiotic treatment, which is a significant health hazard, but the source does not report specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 57,600 MicroscanrapID/S panels (Internal Number J1025-311; Catalog Number 10444792). These panels are used in conjunction with the Walk Away System to determine antimicrobial agent susceptibility and identification for gram-negative bacteria.
The recall was initiated due to a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and meropenum. These errors may occur when using Synergies plus Negative and rap ID/S plus Negative panels.
The affected products were distributed worldwide, including in the United States and various international markets. Healthcare facilities and laboratories should stop using these panels and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- MicroscanrapID/S panels NC3.11 Sold in Japan 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-negative
- 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 - J1025-311
- Catalog Number - 10444792
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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