AN 1999(05) Abbott in vitro diagnostic products: Additional precautions for use

Please note that contact names and/or numbers may have changed since this notice was published. If you need to contact us about a particular notice, please call on 020 7084 3272 or e-mail dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.
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November 1999

MANUFACTURER/SUPPLIER
Abbott Laboratories Limited (Diagnostics Division)

ISSUE
As a result of apparent failures to comply with local good manufacturing practice requirements at the Abbott Lake County manufacturing site in the USA, adoption of additional quality control measures is recommended with in vitro diagnostic medical devices (IVDs) manufactured at this site.

For the attention of:
Health Authorities (England)- Chief Executives
NHS Trusts (England)- Chief Executives
Clinical Pathology Accreditation (UK) Ltd
Nation Blood Authority

IMMEDIATE ACTION
Until further notice, users are advised to ensure that Abbott IVDS manufactured at Abbott's Lake County facility are used in conjunction with quality control material manufactured by a third party*. These products may be identified by the appearance of the letter 'M' in the lot number (see Background paragraph 6).

DISTRIBUTION REQUIRED
Please bring this advice to the attention of all who need to know or be aware of it. This will include distribution by:

TRUSTS to:

• Liaison Officers (for onward distribution)
• Directors and Managers of Pathology and Laboratory Services
• Clinical Pathologists
• Microbiology Departments
• Virology Departments
• Clinical Chemistry/Chemical Pathology Departments
• Immunology Departments
• Haematology Departments
• Medical Directors

HEALTH AUTHORITIES to:

• Liaison Officers (for onward distribution)
• Registration Inspection Units
• Public Health Laboratory Service
• Independent Healthcare Sector
• Directors of Public Health

BACKGROUND

1. The US Food and Drug Administration (FDA) recently filed a complaint for injunction against Abbott Laboratories in the USA. FDA has stated that they sought this action because of Abbott Diagnostic Division's long-standing failure to comply with FDA's Good Manufacturing Practices regulation, now called Quality Systems Regulation (QSR). The alleged non-compliances relate to the manufacture of IVDs at Abbott's Lake County manufacturing facility in the USA. Without admitting to the allegations of the complaint, Abbott has entered into an agreement, known as a consent decree of permanent injunction, with the FDA.

2. The FDA has indicated that Abbott's failure to comply with current QSR guidelines does not necessarily mean that the products will fail to perform according to the specification. However, users may have less assurance of successful performance than if the products were manufactured in accordance with the FDA's requirements.

3. Under the conditions of the decree, Abbott is prevented from selling certain products in the USA until the FDA validates conformance with current QSR guidelines. The decree allows Abbott to continue to sell, in the USA, a group of products manufactured at Lake County that the FDA has assessed to be medically necessary.

Further information of the consent decree may be found on the FDA Internet sit at www.fda.gov/cdrh

and on the Abbott Internet site at www.Abbott.com

4. Aside from the terms of the decree however, the FDA has recommended that when using the products manufactured at Lake County which remain on the USA market, laboratories should use third party control materials to increase the assurance of successful performance.

5. The decree permits Abbott to continue to export IVDs to countries outside of the USA. Under the terms of the decree, product manufactured in the USA can still be supplied to the UK. For this reason, MDA are recommending that laboratories ensure that Abbott IVDs manufactured at the Lake County facility are used in conjunction with third-party control materials in order to provide increased confidence in the results. This represents no more than good laboratory practice.

6. All Abbott products have an alpha-numeric lot number. While these are of varying length the alpha characters within the lot number always refer to the site of manufacture. The letter "M" is uniquely incorporated into the LOT NUMBER of all Abbott products manufactured at Abbott's Lake County facility. This code system will allow users to positively identify products manufactured at that facility.

7. Abbott products manufactured at Lake County that are used for screening for HIV, HBsAg, and HCV continue to be subject to FDA individual batch screening, according to existing FDA regulations for these products. Furthermore, UK Blood Transfusion Services laboratories conduct pre-acceptance testing before each batch of product is used to screen the blood supply.

8. There is no indication that retesting of patient samples is necessary. Although these devices were not manufactured in conformity with the local QSR, the FDA is not aware of these devices having failed to perform adequately.

9. Users are reminded to report all adverse incidents involving medical devices to the MDA Adverse Incident Centre.

ENQUIRIES
Abbott Laboratories Diagnostic Division in the UK have set up a helpline to deal with any queries regarding the FDA consent decree.

The helpline number is 01628 644225

*Advice on the availability and use of external control material for viral markers may be obtained from:

Virus Reference Division at Central Public Health Library
(Contact: Ms Tina Endericks Tel: 0181 200 4400; Fax: 0181 2001569)

and

Division of Virology at the National Institute for Biological Standards and Control
(Contact: Dr Morag Ferguson Tel: 01707 654753; Fax 01707 646730)

Enquiries to the MHRA should quote reference number FGA/96/00/001.