The Recall Desk
ModerateFDA (Devices)·Z-2438-2018·Announced 2018-07-25

Siemens Dimension Vista MULTI 2 SDIL Diluent Recall for Defective Septum

Siemens is recalling 1,195 units of Dimension Vista MULTI 2 SDIL diluent because a defective septum may cause erroneously elevated test 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 II. The hazard involves a defect that may lead to erroneous test results rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity recall involving potential diagnostic errors.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,195 units of Dimension Vista MULTI 2 SDIL diluent (KD694, SMN# 10483586). The recall involves specific lots with expiration dates in September and November 2018. The products were distributed to numerous US states, US territories, and multiple international countries.

The recall is due to a potential defect where the diluent vial cap may have an incomplete slit on the septum. If a sample is autodiluted onboard the system using a vial with this defect, a reduced volume of diluent may be pipetted, which has the potential to cause erroneously elevated test results.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled product, nor does it report any specific illnesses or injuries associated with the defect.

The recalled product

Product
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
1,195

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 (6)

  • lot 7CDA79
  • UDI # (UDI) 008427680324177CDA7918090110483586
  • exp 2018-09-01
  • lot # 7DDA70
  • UDI # (UDI) 008427680324177DDA7018110110483586
  • exp 2018-11-01

Distribution

Distributed in 53 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · erroneous results

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