FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
- Recall Initiated
- February 13, 2018
- Terminated
- April 3, 2019
- Recall Number
- Z-1798-2018
- Quantity
- 18
Reason for Recall
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
Distribution
Distributors in 2 states: NY and IL.
Lot / Code Info
Serial Numbers: Accelerator a3600 - ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214 FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181 Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095 Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
Root Cause
Device Design
Action Taken
On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, giorgia.amabile@inpeco.com, (+41) 91 9118 258.