Class 2 Device Recall Alere Afinion" HbA1c and ACR on Afinion" 2 analyzer

• Date Initiated by Firm: June 17, 2024
• Date Posted: August 27, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2736-2024
• Recall Event ID: 94910
• 510(K)Number: K171650
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• Product: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
• Code Information: Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
• Recalling Firm/ Manufacturer: Abbott Diagnostics Technologies AS; Kjelsasveien 161; Oslo Norway
• For Additional Information Contact: David Gillooly; 47 22 042000
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Reprocessing Controls
• Action: 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.
• Quantity in Commerce: 5 analyzers
• Distribution: US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LCP