Siemens Atellica IM1300 Analyzer Recall for Insufficient Sample Detection Failure
Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples 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. The hazard involves a risk of harm (failure to detect insufficient samples) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 927 units of the Atellica Solution IM1300 Analyzer (Siemens Material Number 11066001, UDI # 00630414007960). The recall is due to a defect where the analyzer may not detect insufficient sample volumes when used with Tube Top Sample Cups (TTSC) or V-shaped Sample Cups.
The affected analyzers were distributed worldwide, including to numerous US states and Puerto Rico. The specific sample containers involved in this issue include Atellica Tube Top Sample Cups (1 mL and 2 mL) and Sarstedt 62.612 4 mL cups.
Healthcare facilities and laboratories should stop using the affected analyzers with the specified sample containers and contact Siemens Healthcare Diagnostics for further instructions on remediation or replacement.
The recalled product
- Product
- Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 927
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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