The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems."

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 →

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