Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 57,600 units of Microscan plus Negative Urine Combo 4 panels. The recall is due to a confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum. These errors occur when using Synergies plus Negative and rap ID/S plus Negative panels read on the Walk Away System.
The affected product is used for determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. The panels were distributed worldwide, including in the United States and various international locations. The internal number for the recalled product is B1016-202 and the catalog number is 10444601.
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 Urine Combo 4 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 gra
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- 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 - B1016-202
- Catalog Number - 10444601
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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