Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica IM 1300 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc Due to Ancillary reagent packs used on Atellica IM 1300...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc directly.
Affected Products
Atellica IM 1300 Analyzer, SMN 11066001
Quantity: 1193
Why Was This Recalled?
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Where Was This Sold?
This product was distributed to 23 states: AZ, CA, CO, GA, ID, KS, MO, MT, NE, NV, NM, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WY
About Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report