Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Atellica IM 1300 Analyzer, SMN 11066001

FDA Recall Z-0124-2022 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2021-09-28
Product Quantity1193

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.

Firm Action

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.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑