Skip to content

Alinity recallZ-1480-2024 · Abbott GmbH · initiated Mar 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

FDA root cause category: Device Design

What the company is doing

Abbott issued an Urgent Product Correction notice to its consignees on 03/04/2024 via FedEx. The notice explained the issue, impact on patient results, and requestee the following: Installation of the most current assay file version(s) of the assay(s) used by your laboratory. The new assay file(s) may be requested from Abbott Mail for systems connected to AbbottLink. Alternatively, for systems not connected to AbbottLink, the revised assay file may be downloaded from www.corelaboratory.abbott. Installation of the new assay file version will require new calibration as per ARCHITECT System / Alinity ci series Operations Manual. Therefore, please deplete your current on board ARCHITECT Anti-HCV, ARCHITECT AdviseDx SARS-CoV-2-IgG II and Alinity i Anti-HCV reagent kits before installing the new assay file versions and perform a manual backup. For additional support for the new assay file installations, please contact your customer service representative. " Previously reported Alinity i Anti-HCV, ARCHITECT Anti-HCV test results may be reviewed with the Medical Director or Laboratory Management per the laboratory protocol. " For diagnostic purposes, Alinity i Anti-HCV, ARCHITECT Anti-HCV results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic hepatitis C infection. " If you have forwarded the Alinity i Anti-HCV, ARCHITECT Anti-HCV and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II product to other laboratories, please inform them of this Product Correction and provide them a copy of this letter. " Complete and return the Customer Reply Form. " Please retain this letter for your laboratory records. For questions regarding this information, please contact Customer Service at 1-877-4 ABBOTT (available 24 hours a day, 7 days a week).

Recall details

Recall number
Z-1480-2024
Status
Open, Classified
Initiated by the company
Mar 4, 2024
Posted by the FDA
Apr 4, 2024
Recalling firm
Abbott GmbH
Quantity
5110 units
Product code
MZO
FDA submissions
P050042
Distribution
US Nationwide distribution.

Product description

Alinity i Anti-HCV Reagent Kit, List Number 08P0521

Code information (models, lots, serial numbers)

UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under P050042 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94205).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page