Atellica IM 1300 Analyzer. In vitro diagnostic testing recall: Software Issue
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica…
Why was Atellica IM 1300 Analyzer. In vitro diagnostic testing recalled?
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software in V 1.14.2 and lower.
- Product
- Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 217 units
- Distribution
- Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam.
- Recall date
- February 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)