Atellica IM 1600 Analyzer, SMN 11066000
- Recall Initiated
- September 28, 2021
- Recall Number
- Z-0125-2022
- Quantity
- 1733
- Firm Location
- East Walpole, MA
Reason for Recall
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.
Distribution
Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
Lot / Code Info
All units.
Root Cause
Under Investigation by firm
Action Taken
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.