Abbott GmbH: Medical Device Recall in 2024 - (Recall #: Z-1480-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 4, 2024

Date Posted: April 10, 2024

Recall Number: Z-1480-2024

Event ID: 94205

Reason for Recall:

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).

Status: Ongoing

Product Quantity: 5110 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated