Recipient: Beckman Coulter, Inc.
Product: Class II diagnostic chemistry analyzers, reagents, calibrators and controls
Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g).
Validation of device software was not performed. Specifically, the Integrated UniCel DxC analyzers in commercial clinical use have either a VME Motorola ICS board or a PowerPC board running the software. When validating the software version change to (b)(4) your firm did not do system integration testing on the VME board. Neither did it conduct a code review of the software change for the VME board. Version (b)(4) was released to the field in late 2009. It was subsequently determined that the (b)(4) software running on the VME board had a bug introduced by the change and a recall (Z-2590-2010) was necessary in February 2010.
FDA office: Los Angeles District Office