Z-0124-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1193
Product Description
Atellica IM 1300 Analyzer, SMN 11066001
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 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.
Code Information
All units