A Medical Device Daily

Ortho-Clinical Diagnostics (Raritan, New Jersey), abusiness ofJohnson & Johnson (New Brunswick, New Jersey), said it has initiated a nationwide voluntary product recall of a reagent used with its Vitros immunodiagnostic ECi/ECiQ laboratory test system because the reagent may produce inaccurate tests results in some cases.

This reagent is a special chemical used in the test system by laboratories to test patient samples.

The reagent being recalled is the Vitros immunodiagnostic products signal reagent (SR), used on the Vitros system. The test system is used in clinical laboratories to screen for more than 40 diseases and conditions.

This recall affects two of 50 lots of this reagent (about 4%) currently in distribution globally. One lot being recalled was distributed in the U.S., and one in countries outside the U.S.

Inaccurate test results may affect test outcomes in these critical areas: cardiac; hepatitis; thyroid disorders; HIV and pregnancy. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results are recommended to discuss this matter with their physicians.

Ortho-Clinical Diagnostics has advised laboratories using this reagent to contact the patient's physician if there are any concerns regarding previous test results.

The company said it initiated a voluntary product recall by notifying all distributors and customers with one of the systems.

Customers with the affected lots were asked to immediately discontinue using any remaining Vitros SR Lot 8350 or 8530 if alternate lots were in inventory and to follow an enhanced quality control procedure for all lots of Vitros SR until further notice. This precautionary measure is designed to identify any potential packs of affected Vitros SR.

Ortho-Clinical Diagnostics notified its customers and distributors by letter of this recall on March 28. The FDA was apprised of this action.

In another action, Ossur (Reykjavik, Iceland) reported a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee prosthetic device.

The company's initiation of the recall is based on a finding that some units of the device may contain faulty pins based in the axis of the knee.

At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company. To date, the incidence of actual product failures within the recalled knees is less than 1%.

The serial numbers of the affected knees, which were ordered from June 7, 2005, to the present, have been identified and the facilities who have provided a Total Knee that contains the affected serial number will receive a letter and a phone call with the proper replacement procedures.

In addition, Ossur has temporarily suspended sales and shipments of the devices until further notice. The implementation of a replacement program will be effective immediately.

“We take the issue of patient safety very seriously,“ said Jon Sigurdsson, president and CEO of Ossur, said, “We instituted this recall immediately, upon learning of the faulty pins, because we believe that the patient's wellbeing is our first priority. In addition, we are taking measures to guarantee the quality and safety of the replacement knees.“

Ossur has informed the FDA and regulatory authorities in other countries of the recall.

CombiMatrix receives CLIA certification

Acacia Research (Newport Beach, California) reported its CombiMatrix (Mukilteo, Washington) group's wholly owned subsidiary, CombiMatrix Molecular Diagnostics (CMDX; Irvine, California), has received certification to operate as a clinical laboratory in accordance with the Clinical Laboratory Improvement Act (CLIA).

“This is an important milestone for our company,“ said Matt Watson, CEO of CMDX. “Since opening our doors in May of 2005 we have been working diligently to establish a program of processes and procedures that would meet CLIA's strict quality control and quality assurance standards. Now that we have met those standards we are cleared to begin offering high quality clinical testing services at our state-of-the-art laboratory in Irvine, California.“