Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,158 boxes (43,160 panels) of Microscan Synergies Plus Negative Combo 2. This 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 products were distributed worldwide, including in the United States and various international countries. The specific lot codes and expiration dates range from June 2012 to May 2014. Users should stop using these panels and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Microscan Synergies Plus Negative 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 bacteria.
- 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 (16)
- Internal Number - B1025-108
- Catalog Number - 10444747
- Lot code/expiration date: 2012-06-27
- 2012-06-27
- 2012-08-10
- 2012-10-12
- 2012-11-30
- 2013-01-06
- 2013-02-01
- 2013-03-27
- 2013-10-02
- 2013-11-21
- 2014-01-24
- 2014-03-28
- 2014-05-03
- 2014-05-03.
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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