Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 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 with a confirmed defect leading to inaccurate diagnostic results for critical antibiotics, which poses a risk of harm through potential treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,324 boxes (26,480 panels) of Microscan Synergies Plus Negative Urine Combo 2. The product is used to determine antimicrobial agent susceptibility and identification for gram-negative bacteria.
The recall was initiated because of a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and/or meropenum when using Synergies plus Negative and rap ID/S plus Negative panels read on the Walk Away System. The affected lots have expiration dates ranging from July 12, 2012, to June 11, 2014.
The product was distributed worldwide, including nationwide in the United States and in numerous international countries. Users should stop using the affected panels and contact Siemens Healthcare Diagnostics for instructions on returning the product.
The recalled product
- Product
- Microscan Synergies Plus Negative Urine Combo 2 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 bacteri
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (6)
- 2012-07-12
- 2012-10-03
- 2013-06-08
- 2013-12-17
- 2014-04-22
- 2014-06-11
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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