Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

FDA device recall Z-1349-2023 · posted 2023-04-06 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

Reason for recall

The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.

Action taken

The field service engineer installed the missing plunger assembly in the clamp bar while at the consignee location on 11/11/2022. The recalling firm issued the recall letter on 3/1/2023 via overnight mail to their sole consignee. The letter explains the issue, the potential impact, and the necessary actions, which includes placing the impacted ADU out of service and contacting Abbott technical support regarding concerns about the performance of the instrument or results. The letter is to be reviewed with the Medical Director or Laboratory Management and the consignee is to follow their laboratory protocol regarding the need for review of previously reported patient results using the affected system. A customer reply form is enclosed with the letter to acknowledge receipt and to indicate it was disseminated to all users, understood, and implemented. If you have any questions regarding this communication, please contact your local Abbott representative or call DVP Quality Assurance, at 224-361-7000.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OOI

Quantity affected

1

Distribution

US Distribution to state of: PA, a government account.

Date initiated

2022-11-11

Date posted

2023-04-06

Location

Des Plaines, IL