Agency classClass IOur severity:Critical FDA (Devices)·Z-2124-2013·Announced 2013-09-18

Siemens Microscan Plus Negative Combo 3 Recalled for Misreads

Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads 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 source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a score of 5 (Critical).

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 57,600 Microscan plus Negative Combo 3 panels. The recall is due to a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and/or meropenum. These panels are used with the Walk Away System to determine antimicrobial agent susceptibility and identification for gram-negative bacteria.

The affected product, identified by Internal Number B1016-201 and Catalog Number 10444600, was distributed worldwide. In the United States, the product was sold in Alaska, South Carolina, Iowa, Missouri, Georgia, Wisconsin, Texas, Kansas, California, Illinois, Colorado, Arizona, South Dakota, Indiana, Maryland, Florida, and Minnesota. The product was also distributed in numerous countries including Japan, France, Germany, and the United Kingdom.

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 Combo 3 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…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
false-positive
false-negative
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 - B1016-201
Catalog Number - 10444600

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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.

See all 11 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · mis labeling