Alinity m System, Part No. 08N53-002
Recall
- Recall Number
- Z-0463-2022
- Event Number
- 89169
- Firm
- Abbott Molecular, Inc.
- FEI Number
- 3005248192
- Product Code
- MZP
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 6, 2021
- Terminated
- September 30, 2024
- Address
- 1300 E Touhy Ave, Des Plaines, IL, 60018-3315
Description
Alinity m System, Part No. 08N53-002
There is an issue with the installation of updated camera firmware on the system.
On December 06, 2021 Abbott Molecular issued a Product Correction letter to all customers who received an Alinity m instrument impacted by this issue (List Number 08N53 002). Customers are being informed of a previously completed assessment conducted by Abbott FSEs. Customers were initially informed at the time of the assessment, but proper reconciliation of the communication was not performed. 100% of customers are requested to return to Abbott a Customer Reply Form acknowledging receipt and understanding, and/or a request for assistance. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam
74 devices