Abbott GmbH: Anti-HCV Reagent Kits Recalled for Falsely Elevated Patient Results

Agency Publication Date: April 4, 2024

Summary

Abbott GmbH is recalling 12,329 units of ARCHITECT and Alinity i Anti-HCV Reagent Kits because they can produce falsely elevated or "false positive" hepatitis C results. This issue occurs when certain other tests—specifically syphilis or SARS-CoV-2 (COVID-19) antibody tests—are processed on the same instrument immediately before the hepatitis C test. Customer complaints and internal studies confirmed these potential interactions, which could lead to incorrect medical diagnoses.

Risk

A falsely elevated result may lead a healthcare provider to incorrectly believe a patient has a hepatitis C infection, potentially resulting in unnecessary medical procedures, psychological distress, or inappropriate treatment plans.

What You Should Do

Identify if your laboratory or clinic uses ARCHITECT Anti-HCV Reagent Kits with List Numbers 1L79-25 or 1L79-35. Check for Lot Numbers 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00, 52015BE00, 54144BE00, 56379BE00, 58167BE00, or 59198BE00.
Identify if your laboratory or clinic uses Alinity i Anti-HCV Reagent Kits with List Number 08P0521. Check for UDI/DI 00380740130657 and Lot Numbers 52020BE00, 54149BE00, 56384BE00, 58172BE00, or 59203BE00.
Review testing sequences on your instruments to determine if ARCHITECT Syphilis TP (LN 8D06) or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) was run immediately before an Anti-HCV test.
Review testing sequences for Alinity i instruments to see if Alinity i Syphilis TP (LN 07P60) was run immediately before an Alinity i Anti-HCV test.
Contact your healthcare provider or Abbott GmbH for technical guidance on interpreting past results or modifying instrument testing protocols.
Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this device recall.

Your Remedy Options

Other Action

Protocol modification and healthcare consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ARCHITECT Anti-HCV Reagent Kit (List Number 1L79-25)

Model / REF:

1L79-25

UPC Codes:

00380740001414

Lot Numbers:

52011BE00

54140BE00

56375BE00

58163BE00

59194BE00

Product: ARCHITECT Anti-HCV Reagent Kit (List Number 1L79-35)

Model / REF:

1L79-35

UPC Codes:

00380740001421

Lot Numbers:

52015BE00

54144BE00

56379BE00

58167BE00

59198BE00

Product: Alinity i Anti-HCV Reagent Kit (List Number 08P0521)

Model / REF:

08P0521

UPC Codes:

00380740130657

Lot Numbers:

52020BE00

54149BE00

56384BE00

58172BE00

59203BE00

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94205

Status: Active

Manufacturer: Abbott GmbH

Sold By: Abbott GmbH; Medical laboratories; Hospitals

Manufactured In: Germany

Units Affected: 2 products (7219 units; 5110 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your laboratory or clinic uses ARCHITECT Anti-HCV Reagent Kits with List Numbers 1L79-25 or 1L79-35. Check for Lot Numbers 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00, 52015BE00, 54144BE00, 56379BE00, 58167BE00, or 59198BE00.

Identify if your laboratory or clinic uses Alinity i Anti-HCV Reagent Kits with List Number 08P0521. Check for UDI/DI 00380740130657 and Lot Numbers 52020BE00, 54149BE00, 56384BE00, 58172BE00, or 59203BE00.

Review testing sequences on your instruments to determine if ARCHITECT Syphilis TP (LN 8D06) or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) was run immediately before an Anti-HCV test.

Review testing sequences for Alinity i instruments to see if Alinity i Syphilis TP (LN 07P60) was run immediately before an Alinity i Anti-HCV test.

Contact your healthcare provider or Abbott GmbH for technical guidance on interpreting past results or modifying instrument testing protocols.

Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this device recall.

Affected Products

Product: ARCHITECT Anti-HCV Reagent Kit (List Number 1L79-25)

Model / REF:

1L79-25

UPC Codes:

00380740001414

Lot Numbers:

52011BE00

54140BE00

56375BE00

58163BE00

59194BE00

Product: ARCHITECT Anti-HCV Reagent Kit (List Number 1L79-35)

Model / REF:

1L79-35

UPC Codes:

00380740001421

Lot Numbers:

52015BE00

54144BE00

56379BE00

58167BE00

59198BE00

Product: Alinity i Anti-HCV Reagent Kit (List Number 08P0521)

Model / REF:

08P0521

UPC Codes:

00380740130657

Lot Numbers:

52020BE00

54149BE00

56384BE00

58172BE00

59203BE00