Siemens Microscan rapID/S panels recalled for false susceptibility results
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads 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 that provides diagnostic information for antibiotic treatment. While no injuries or illnesses are reported, the risk of incorrect susceptibility results (false susceptible/intermediate) poses a significant risk of harm to patients by potentially leading to inappropriate antibiotic therapy. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Microscan rapID/S panels NC3.33. These panels are used to determine antimicrobial agent susceptibility and identification for gram-negative bacteria. The recall involves 57,600 panels in total.
The recall was initiated because of a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and meropenum. These misreads occurred when the panels were read on the Walk Away System. The affected products include Synergies plus Negative and rap ID/S plus Negative panels.
The products were distributed worldwide, including in the United States and various international markets. Healthcare facilities and laboratories that use these panels for antimicrobial susceptibility testing should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on how to proceed.
The recalled product
- Product
- Microscan rapID/S panels NC3.33 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 - J1025-333
- Catalog Number - 10444794
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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