The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2405-2020·Announced 2020-07-01

Siemens Atellica Solution IM1600 Analyzer Recall for Sample Detection Issues

Siemens is recalling Atellica Solution IM1600 Analyzers because insufficient sample volumes may not be detected when using specific sample cups.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate test results due to undetected insufficient samples) where specific injury reports are not detailed in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,329 units of the Atellica Solution IM1600 Analyzer (Siemens Material Number 11066000, UDI # 00630414002026). The recall is due to a defect where the analyzer may fail to detect insufficient sample volumes when used with Tube Top Sample Cups (TTSC) or V-shaped Sample Cups.

The affected units were distributed worldwide, including to numerous U.S. states and Puerto Rico. The specific sample containers involved in the issue include Atellica Tube Top Sample Cups (1 mL and 2 mL) and Sarstedt 62.612 cups. This is classified as a Class II recall by the FDA.

Healthcare facilities and users should stop using the affected analyzers with the specified sample cups and contact Siemens Healthcare Diagnostics for instructions on replacement or repair.

The recalled product

Product
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Laboratory Analyzer
Hazard
Affected units
1,329

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)

  • Atellica Tube Top Sample Cups
  • 1 mL
  • SMN 11069061
  • 2 mL
  • SMN 11069062
  • Sarstedt 62.612
  • 15.3 x 92 False Bottom
  • 4 mL

Distribution

Distributed in 44 states:

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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