CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report

Architect Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79 recalled

Abbott is recalling Architect Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35, distributed nationwide in the US. The recall was initiated on 4 Mar 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00

Quantity recalled7219 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1479-2024
FDA event ID: 94205
Recalling firm: Abbott, Wiesbaden
Classification: Class II
Status: Ongoing
Recall initiated: 4 Mar 2024
FDA classified: 4 Apr 2024
Reported: 10 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

4 Mar 2024	Recall initiated by company
4 Apr 2024	Classified by FDA	+31 days
10 Apr 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 94205

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024	CLASS II	Alinity i Anti-HCV Reagent Kit, List Number 08P0521 recalled by Abbott	Abbott	Other	Nationwide

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