Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
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 source metadata explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 57,600 units of the Microscan plus Negative Breakpoint Combo 4. The product is used to determine antimicrobial agent susceptibility and identification for gram-negative bacteria. The recall is due to a confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum when using Synergies plus Negative and rap ID/S plus Negative panels on the Walk Away System.
The affected products were distributed worldwide, including in the United States and numerous international countries. The specific internal number for the recalled items is B1016-203, and the catalog number is 10460272.
Healthcare facilities and users should stop using the affected panels and contact Siemens Healthcare Diagnostics for instructions on how to proceed. This recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Microscan plus Negative Breakpoint 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…
- 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 - B1016-203
- Catalog Number - 10460272
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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