Siemens Healthcare Diagnostics, Inc Atellica IM 1300 Analyzer, SMN 11066001 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica IM 1300 Analyzer, SMN 11066001
Brand
Siemens Healthcare Diagnostics, Inc
Lot Codes / Batch Numbers
All units
Products Sold
All units
Siemens Healthcare Diagnostics, Inc is recalling Atellica IM 1300 Analyzer, SMN 11066001 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On September 27, 2021, the firm initiated notifications to affected customers. Customer distribution included all customers located in a city at an altitude of 350 meters (1148 feet) or higher. Customers were informed that 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 350 (m) or 1148 (ft) above sea level. The letters provide directions for mitigating the potential for leakage. If you have any questions, contact your local Siemens Healthineers technical support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, GA, ID, KS, MO, MT, NE, NV, NM, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WY
Page updated: Jan 10, 2026