The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2129-2013·Announced 2013-09-18

Siemens Microscan rapID/S panels recalled for false susceptibility results

Siemens Healthcare Diagnostics is recalling Microscan rapID/S 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 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: "Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System."

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Microscan rapID/S panels NC3.33. These panels are used to determine antimicrobial agent susceptibility and identification for gram-negative bacteria. The recall involves 57,600 panels in total.

The recall was initiated because of a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and meropenum. These misreads occurred when the panels were read on the Walk Away System. The affected products include Synergies plus Negative and rap ID/S plus Negative panels.

The products were distributed worldwide, including in the United States and various international markets. Healthcare facilities and laboratories that use these panels for antimicrobial susceptibility testing should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on how to proceed.

The recalled product

Product
Microscan rapID/S panels NC3.33 Sold in Japan 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
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 - J1025-333
  • Catalog Number - 10444794

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 →

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