MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M HCV AMP KIT; ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITI

Catalog Number 08N50-095

Device Problems False Positive Result (1227); Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Through complaint investigation, abbott has identified an increase in potential for reactive negative controls (nc) as well as separate instances of false positive results in patient samples when using specific lots of alinity m hcv amp kit.It was discovered that these specific lots of alinity m hcv amp kit have lower than the expected range of hcv reference dye fluorescence.A product deficiency was identified for these specific lots of alinity m hcv assay.The potential hazards associated with this issue are incorrect results (false positive) and delay of results (reactive nc requiring a re-test).Field action fa-am-oct2023-293, was taken to address this issue.It was deemed reportable per 21cfr806 and therefore will be reported under 21cfr803.

Manufacturer Narrative

Based on the customer data review of the complaint investigation, it was identified that the amplification curves for a majority of samples were not sigmoidal and have a data reduction issue for the fam target.It was discovered that specific lots of alinity m hcv amp kit have lower than the expected range of hcv reference dye fluorescence and resulted in an artificial non-sigmoidal amplification curve and false positive results.Therefore, the complaint was dispositioned as confirmed for product deficiency.The following material lot information is included in this confirmed product deficiency.List number: 08n50-090 lot number: 383203, date of manufacture: 03/27/2023, expiration date: 12/30/2024 (b)(4) lot number: 385720, date of manufacture: 05/11/2023, expiration date: 02/26/2025 ,(b)(4) lot number: 381581, date of manufacture: 12/20/2022, expiration date:10/06/2024, (b)(4)lot number: 382447, date of manufacture: 02/07/2023, expiration date: 11/11/2024, (b)(4) list number: 08n50-095 lot number: 381582, date of manufacture: 01/04/2023, expiration date:10/06/2024, (b)(4) lot number: 382448, date of manufacture: 03/01/2023, expiration date:11/11/2024, (b)(4)on (b)(6) 2023, a decision was made to issue a customer letter (urgent field safety notice / field correction recall) to notify customers of the reported issue.Field action fa-am-oct2023-293, was issued on (b)(6) 2023.It was deemed reportable per 21cfr806 and therefore will be reported under 21cfr803.Initial notification to the fda per 21cfr806 was completed on (b)(6) 2023.

Manufacturer Narrative

Updated field action fa-am-oct2023-293v2 was issued on july 23, 2024, to notify customers that material impacted by the issue was not segregated as required and an additional lot of impacted alinity m hcv amp kit list number 08n50-095 was distributed.Initial notification to the fda of this updated field correction recall was completed on july 24, 2024.The following material lot information is included in this confirmed product deficiency: list number: 08n50-095.Lot number: 383204, date of manufacture: 2024-01-22, expiration date: 2024-12-30.Udi: (b)(4).

• Brand Name: ALINITY M HCV AMP KIT
• Type of Device: ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITI
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 18089017
• MDR Text Key: 328417556
• Report Number: 3005248192-2023-00279
• Device Sequence Number: 1
• Product Code: MZP
• UDI-Device Identifier: 00884999047761
• UDI-Public: (01)00884999047761(10)381582(17)241006(240)08N50-095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/06/2024
• Device Catalogue Number: 08N50-095
• Device Lot Number: 381582
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 07/18/2024
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3005248192-10/30/23-002R
• Patient Sequence Number: 1