Recall Z-2736-2024 ยท LCP Assay, Glycosylated Hemoglobin
Abbott Diagnostics Technologies AS
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
| Date | Aug 27, 2024 (initiated Jun 17, 2024) |
| Status | Open, Classified |
| 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. |
| Root 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 |
| Quantity | 5 analyzers |
| Distribution | US Nationwide distribution in the states of AZ, IN, MA, MN, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer Abbott Rapid Diagnostics, Nov 21, 2017 |