Device product
Atellica IM 1300 Analyzer, SMN 11066001
Z-0124-2022
Product summary
- Event
- Event 88792
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1193
- Official record key
device-enforcement:Z-0124-2022
Official wording
Reason: 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.
Code information: All units
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.