Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417) Recalled by Siemens Healthcare Diagnostics, Inc. Due to The product has the potential for false negative...

Date: May 2, 2013
Company: Siemens Healthcare Diagnostics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.

Affected Products

Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.

Quantity: 683 units

Why Was This Recalled?

The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report