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Q’s and A’s – Abbott’s In Vitro Diagnostic Products

FDA is taking this action because of Abbott Diagnostic Division’s (Abbott’s) long-standing failure to comply with FDA’s Good Manufacturing Practices (GMP) regulation, now called the Quality System (QS) regulation, and Abbott’s repeated failure to fulfill commitments to correct deficiencies in its manufacturing operations for its in vitro diagnostic (IVD) devices.

FDA has conducted numerous GMP/QS regulation inspections at Abbott’s primary IVD manufacturing locations in Abbott Park and North Chicago (K2 facility), IL. The most recent FDA inspection concluded on July 8, 1999. These inspections showed non-compliance with GMP/QS regulation requirements involving process validation, corrective and preventative action, and production and process controls, among others.

Process validation establishes, by objective evidence, that a process (e.g., manufacturing) will consistently produce a product that meets its predetermined specifications.

One of the areas of non-compliance identified during inspections at Abbott was process validation. Some manufacturing processes require additional assurances and measures to ensure they consistently result in product that meets predetermined specifications. These additional assurances are necessary because these manufacturing processes cannot be fully verified by subsequent inspection and testing. These additional assurances and measures are achieved through what is called process validation.

When a manufacturer complies with the GMP/QS regulation, there is a level of assurance that the product has been designed and manufactured in a consistent way and will perform as intended. Conversely, a manufacturer who fails to comply is less likely to produce a product that performs as intended. FDA is especially concerned about Abbott’s long-standing non-compliance with these accepted manufacturing principles because they represent the minimum requirements for manufacturing quality.

Abbott’s failure to comply with GMP/QS regulation requirements does not mean that its in vitro diagnostic devices will necessarily fail to perform as intended. It does mean that users have less assurance of successful performance than they would have had if these products had been manufactured properly.

Abbott manufactures approximately 300 in vitro diagnostic devices. Of these 300 devices, 14 are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) and the remaining 286 are regulated by FDA’s Center for Devices and Radiological Health (CDRH). The devices regulated by CBER are primarily used in screening donor blood for transfusion. The devices regulated by CDRH are used in several areas of the clinical laboratory to make diagnoses, including clinical chemistry, hematology, immunology, and toxicology.

FDA examined Abbott’s products and determined that certain in vitro diagnostic devices could not be removed from the marketplace without compromising patient care. FDA determined that several assays used in screening donor blood were critical for the continued testing and distribution of blood for transfusion. A number of assays for clinical chemistry, cardiac markers and therapeutic drug monitoring needed to be available for a certain period of time to those users who cannot find suitable alternatives. As more information becomes available, FDA will communicate with the medical community on specific precautions that can be taken to help ensure that those Abbott in vitro diagnostic devices that remain in the marketplace perform as intended.

CBER products

On September 15, 1999, FDA informed Abbott that all of its viral marker test kits used to test donor blood are now subject to lot release by FDA’s Center for Biologics Evaluation and Research (CBER). Lot release by FDA provides an added assurance of the sensitivity of the test kits used to screen donor blood because a test kit from a particular lot is required to "pass" a panel of samples containing various levels of specific viral marker, including samples with very low levels of that viral marker. These lot release panels also contain negative samples to check specificity. Due to this additional control measure, FDA believes that these in vitro diagnostic test kits can continue to be used.

FDA is recommending the use of quality control materials (reagents used to help verify the proper functioning of devices) made by other companies to increase the assurance that these devices are performing successfully.

Abbott products currently in the distribution chain may be used for now, if products from alternate manufacturers are not available. However, if Abbott’s in vitro diagnostic devices are used, FDA recommends the use of additional quality control material made by other companies to increase the assurance of successful performance.

FDA is not recommending that diagnostic tests be repeated for those patients whose initial testing was performed using Abbott’s in vitro diagnostic devices. Although these devices were not manufactured in conformity with the Quality System regulation, FDA is not aware of information that these devices (other than ones that have been involved in publicized recalls) have failed to perform adequately.

FDA is not recommending that blood and blood components currently in distribution be retested. Although these kits were not manufactured according to the Quality System regulation, FDA is not aware of information that these devices (other than products that have been involved in publicized recalls) have failed to perform adequately.

FDA is not recommending routine testing of recipients of blood products screened using Abbott’s diagnostic kits. Although these kits were not manufactured according to the Quality System regulation, FDA is not aware of information that these devices (other than products that have been involved in publicized recalls) have failed to perform adequately. Moreover, the blood supply is protected by several layers of overlapping measures that are designed to minimize risk, even in the very unlikely event that any one protective measure should fail.

At the present time, FDA has no information to suggest that donor blood tested using kits manufactured by companies other than Abbott is safer than donor blood tested using Abbott’s in vitro diagnostic test kits.

FDA’s action to lot release all Abbott’s viral marker test kits used to screen donor blood was precautionary. At the present time, FDA has no information to suggest that using Abbott test kits will compromise the safety of the blood supply.

14. If I choose not to use Abbott’s in vitro diagnostic devices, what are my options? (REVISED)

Alternative products are available on the U.S. market. Listings of products regulated by CBER are available on CBER's web site. For current information on alternative manufacturers of devices regulated by CDRH, FDA recommends the use of HCFA recognized proficiency testing survey programs to obtain information on comparable marketed devices.

Updated information will be available on these products, as appropriate, via the internet at http://www.fda.gov/cber. Information will also be available from the CBER voice information system at 1-800-835-4709, the CBER FAX information system at 1-888-CBER-FAX, and to subscribers of CBER's automated mailing system, CBERINFO.

CDRH products

Updated information will be available on these products, as appropriate, via the internet at http://www.fda.gov/cdrh. Information will also be available from the Center for Devices and Radiological Health (CDRH), Division of Small Manufacturers Assistance (DSMA) at 1-800-638-2041 and the CDRH Facts-on-Demand at 1-800-899-0381 document number 1127.

Adverse Events involving malfunctions (i.e., there is no death or serious injury associated with the event) that occur in device user facilities can be reported on a voluntary MedWatch Form. Refer to http://www.fda.gov/medwatch/index.html for a copy of the form and information about voluntary reporting.

An adverse event that has caused, or may cause or contribute to, a death or serious injury must be reported to FDA by device user facilities, importers and manufacturers as required by the Medical Device Reporting Regulation (MDR). Device Importers must report malfunctions to manufacturers and Device Manufacturers must report malfunctions to FDA. All MDR reports are submitted on a Mandatory MedWatch reporting form. Refer to http://www.fda.gov/cdrh/mdr.html for a copy of the form and information about Medical Device Reporting.

Copies of reporting forms and information about MDR reporting can be obtained from http://www.fda.gov/cdrh/mdr.html.

17. If I use Abbott IVDs which have been cleared or approved by FDA in support of a clinical trial, will these products continue to be available after December 6, 1999? (NEW)

All of Abbott's in vitro diagnostic devices that have been deemed medically necessary will continue to be available. A detailed list of these devices may be found on CDRH's web page at http://www.fda.gov/cdrh/ocd/abbott.html. This address also contains a detailed list of the devices which will no longer be available after December 6, 1999. If you are currently conducting a clinical investigation using a cleared or approved Abbott IVD that is on the list to be discontinued, FDA will consider requests for continued availability of a device on a case by case basis. If your request concerns a device regulated by CBER, your request should be directed to the Director of CBER's Office of Compliance and Biologics Quality. If your request concerns a device regulated by CDRH, your request should be directed to the Director of CDRH's Office of Compliance. Such requests should include information as to why an alternative device cannot be used, the nature of the clinical investigation, the device involved, the projected duration of the investigation, and the quantity of the device required to complete the investigation.

Updated November 17, 1999

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