The Recall Desk
ModerateFDA (Devices)·Z-0170-2015·Announced 2014-11-19

Siemens MicroScan Rapid Neg BP Combo Panel Type 3 Recalled for False Positives

Siemens Healthcare Diagnostics is recalling 1,381 units of Rapid Neg BP Combo Panel Type 3 due to an increase in false positive susceptible results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, but the hazard is a diagnostic error (false positives) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity issue involving potential misdiagnosis without reported physical harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,381 units of the Rapid Neg BP Combo Panel Type 3 (Catalog number B 1017-117). This medical device is used with MicroScan Microbiology Systems to determine the species-level identification and antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram-negative bacilli.

The recall was initiated because of an increase in false positive susceptible results observed when using the Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 with MicroScan Microbiology Systems. The affected units were distributed nationwide in the United States, including specific states such as IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, IN, NM, MS, KY, IL, UT, ND, and WY, as well as in Canada.

The affected lots include those with dates 2014-12-10, 2015-02-27, and 2015-06-23. Healthcare facilities and laboratories using these panels should stop using the affected units and contact Siemens Healthcare Diagnostics for further instructions.

The recalled product

Product
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
1,381

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)

  • Catalog number: B1017-117
  • Siemens Material number 1044632
  • lot numbers: 2014-12-10
  • Exp. 2014-12-10
  • 2015-02-27
  • Exp 2015-02-27
  • 2015-06-23
  • Exp 2015-06-23.

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 →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · false positive results

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