Afinion 2 Analyzer…

Date

Sept. 4, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Abbott Diagnostics Technologies AS

Product

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

Reason

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.

Distribution pattern

US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.

Quantity

5 analyzers

Codes and lots

Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.

Recall started

June 17, 2024

Device type

Assay, Glycosylated Hemoglobin

Root cause (FDA)

Reprocessing Controls

What the company told customers

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.

Recall number

Z-2736-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2736-2024. The agency record governs; check it and the company before acting.