The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0171-2015·Announced 2014-11-19

Siemens MicroScan Rapid Urine Combo Panel Recalled for False Positive Results

Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.

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, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 2,239 units of the Rapid Neg Urine Combo Panel Type 1 (Catalog number B 1017-167; Siemens Material Number 10444652). The recall is due to an increase in false positive susceptible results observed when these panels are used with MicroScan Microbiology Systems.

The affected products were distributed nationwide in the United States, including in Iowa, California, New York, Wisconsin, Michigan, South Dakota, North Carolina, Florida, Hawaii, Ohio, Washington, Texas, Indiana, New Mexico, Mississippi, Kentucky, Illinois, Utah, North Dakota, and Wyoming, as well as in Canada. The recall includes specific lot numbers with expiration dates ranging from November 2014 to August 2015.

This recall is classified as Class I by the FDA. Consumers and healthcare facilities should stop using the affected panels and contact Siemens Healthcare Diagnostics for further instructions or replacement.

The recalled product

Product
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and…
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Microbiology Diagnostic Panel
Hazard
Affected units
2,239

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 (18)

  • Catalog number: B1017-167
  • Siemens Material number 1044652
  • lot numbers: 2014-11-01
  • Exp. 2014-11-01
  • 2015-01-03
  • Exp 2015-01-03
  • 2015-02-14
  • Exp 2015-02-14
  • 2015-03-21
  • Exp 2015-03-21
  • 2015-05-20
  • Exp 2015-05-20
  • 2015-06-18
  • Exp 2015-06-18
  • 2015-07-18
  • Exp 2015-07-18
  • 2015-08-11
  • Exp 2015-08-11/

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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