The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2119-2013·Announced 2013-09-18

Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads

Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results 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 Synergies Plus Negative Urine Combo 1 panels. The recall involves 1,209 boxes containing 24,180 panels. The product is used to determine antimicrobial agent susceptibility and identification for gram-negative bacteria.

The recall was initiated due to a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and meropenum. These misreads occur when the panels are read on the Walk Away System. The affected lots have expiration dates ranging from December 5, 2012, to May 21, 2014.

The product was distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities and laboratories should stop using the affected panels and contact Siemens Healthcare Diagnostics for instructions on returning the product.

The recalled product

Product
Microscan Synergies Plus Negative Urine Combo 1 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 gram-negative…
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Laboratory Diagnostic
Hazard

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 (10)

  • Internal Number - B1025-106
  • Catalog Number -10444745
  • Lot code/expiration date: 2012-12-05
  • 2012-12-05
  • 2013-01-16
  • 2013-02-28
  • 2014-01-11
  • 2014-02-11
  • 2014-05-21
  • 2014-05-21.

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 →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls