Atellica IM 1300 Analyzer Reagent Overflow at High Altitudes
Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.
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: This is an FDA Class II recall involving medical diagnostic equipment with no reported illnesses or injuries. The hazard (reagent overflow causing diagnostic test errors) represents a risk of harm through potential misdiagnosis, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1300 Analyzer (SMN 11066001) due to a reagent pack overflow hazard specific to high-altitude locations.
What is being recalled: Ancillary reagent packs used on the Atellica IM 1300 (and IM 1600) analyzers may overflow when pierced during use at altitudes exceeding 350 meters (1,148 feet) above sea level. When this occurs, users experience an increased number of Reagent Volume Check Errors, which can impact test result accuracy.
Who is affected: Approximately 1,193 Atellica IM 1300 units with SMN 11066001 have been distributed domestically throughout the United States and internationally worldwide.
What to do: If your facility is located at an elevation above 350 meters and operates an Atellica IM 1300 analyzer, contact Siemens Healthcare Diagnostics for assistance. This recall was classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- Atellica IM 1300 Analyzer, SMN 11066001
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- reagent-overflow
- diagnostic-error
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 (1)
- All units
Distribution
Distributed in 23 states:
- AZ
- CA
- CO
- GA
- ID
- KS
- MO
- MT
- NC
- NE
- NM
- NV
- OH
- OK
- OR
- PA
- TN
- TX
- UT
- VA
- WA
- WI
- WY
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