Siemens Atellica IM 1600 Analyzer Recalled for Reagent Overflow at High Altitude
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 analyzers that may leak reagent when located at altitudes above 350 meters, potentially causing testing 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 medical device recall with no reported illnesses, injuries, or deaths. The hazard is a potential device malfunction (reagent overflow leading to volume check errors) that could affect test accuracy but has not resulted in patient harm. Per the rubric, recalls without reported adverse events score at most 3 (High).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1600 Analyzer. A total of 1,733 units have been affected.
Ancillary reagent packs used in the analyzer may overflow when pierced if the analyzer is located at an altitude greater than 350 meters (1,148 feet) above sea level. When this overflow occurs, customers may experience an increased number of Reagent Volume Check Errors, which could affect the accuracy of diagnostic test results.
The recalled analyzers have been distributed domestically to 23 U.S. states and internationally worldwide. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Atellica IM 1600 Analyzer, SMN 11066000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- reagent-overflow
- malfunction
- test-inaccuracy
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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