Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall
Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a Critical severity score per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 522 boxes (10,440 panels) of Microscan Synergies Plus Negative Urine Combo 5. The recall is due to 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 nationwide in the United States and in numerous international countries. Specific lot codes and expiration dates are listed in the official recall documentation.
Healthcare facilities and laboratories should stop using the affected panels and contact Siemens Healthcare Diagnostics for instructions on how to return or dispose of the product. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Microscan Synergies Plus Negative Urine Combo 5 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.
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 (8)
- Internal Number - B1025-115
- Catalog Number - 10483101 Lot code/expiration date: 2012-09-22
- 2012-09-22
- 2013-01-20
- 2013-05-07
- 2013-11-01
- 2014-03-05
- 2014-03-05.
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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