Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

The recalling firm issued two different letters dated 6/17/2024 beginning 6/17/2024 via first class mail, one to the distributor and one to the end user customer. The Dear Distributor letter referred the distributor to the enclosed customer notification letter for details on the recall for their reference, as the distributor letter did not contain an explanation for why the recall was being conducted or the impact on patient results. The distributor letter identified the devices that were affected and provided the following actions to be taken: (1) Abbott Diagnostics Technologies AS will be sending a letter on their behalf to impacted customers within the scope of the serial numbers noted in the letter; and (2) Please acknowledge receipt of this letter within 5 business days after receipt using the enclosed distributor acknowledgement form. The distributor is to acknowledge they have received the notification letter and that if they encounter any questions regarding the recall, they will direct them to Abbott Technical Services. The customer letter provided an explanation as to the issue, the impact on patient results or operator safety, and the necessary actions to be taken, which included: (1) Complete and return the "Customer Required Action" form accompanying the letter; (2) If the devices listed have been forwarded to other laboratories, the customer is requested to inform them of the recall and provide a copy of this letter; (3) Retain the letter for their laboratory records. The Customer Required Action form reports that the customer acknowledged receipt of the notice, confirms that all areas where the product could be located have been checked, and lists a number of steps that have been verified with regard to whether they have the affected instruments, were they redistributed to another facility, send a replacement, etc.