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.
What this means for you
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.
- 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
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.
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