The Boston Salads and Provisions company has recalled more than 200,000 pounds of ready-to-eat chicken salad products due to contamination with the listeria bacteria, according to federal regulators. The food, produced between Aug. 23 and Oct. 14, was shipped to retail locations in Massachusetts and New Hampshire, the USDA’s Food Safety and Inspection Service said in a statement. The tainted products could be marked with sell-by dates ranging from Sept. 13 through Nov. 4 and could have the number P-17999 inside the USDA mark of inspection. The recalled chicken products are spread over six brands: Boston Salads, Price Chopper, Dietz & Watson, Market Source, Northern Haserot, and Rachael’s Gourmet. A full list of the recalled products can be found on the USDA’s website. – See more at: http://www.boston.com/metrodesk/2013/10/25/listeria-concerns-prompt-recall-pounds-chicken-salad-products-boston-company/OT4LQV2vnDE6n2UboLWLqL/story.html#sthash.Z8LyH7QM.dpuf                   

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy

FDA grants CLIA-waived status to CoaguChek XS Plus system for PT/INR testing at the point of care

INDIANAPOLIS, Oct. 1, 2012 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

“The waived status of CoaguChek XS Plus system allows healthcare professionals in CLIA-waived environments access to new tools and connectivity options to help them manage patients on warfarin therapy,” said Rod Cotton, senior vice president, professional diagnostics, physician office laboratory, and medical and scientific affairs, at Roche Diagnostics Corporation. “The technology has several features that help ensure fast, accurate results, and the connectivity capabilities help healthcare providers with regulatory compliance, making it easier for them to manage their anticoagulation practices.”

The CoaguChek XS Plus system offers the ability to connect and transfer data to IT solutions, including TELCOR QML, RALS-Plus with expanded device configuration capabilities or through the POCT1A standard data transfer protocol. Implementing connectivity with the CoaguChek XS Plus enables data transfer and reporting capabilities to help hospital staff streamline the regulatory compliance process, capture reimbursable costs and improve their organizational efficiency.

The system uses two-level, built-in quality controls to help ensure the accuracy of PT/INR test results, but also offers optional liquid quality controls for facilities with policies requiring the use of external quality control measures.

About CLIA-waived tests CLIA extended federal regulation of laboratory testing to all types of testing sites and based regulation on the complexity of tests, not the type of lab where the testing occurs. The statute established three categories of tests: waived tests, moderate-complexity tests and high-complexity tests. Waived tests — simple tests with small chance of error or risk — are exempt from virtually all CLIA rules, so long as testing is performed in strict compliance with the manufacturers’ instructions. Moderate- and high-complexity testing, on the other hand, is subject to regulations setting minimum qualifications for all persons performing or supervising these tests, along with corresponding responsibilities for each position in the lab and other requirements. For more information, see www.cms.hhs.gov/CLIA.

About the CoaguChek family of products Clinicians have been using CoaguChek systems for PT/INR (Prothrombin Time/International Normalized Ratio) testing since 1994. The CoaguChek XS Plus system, which provides results in about a minute and has a 97-percent correlation to lab analyzer results (Dade Sysmex 560), represents the fifth generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics. Today in the U.S., more CoaguChek test strips are sold for point-of-care anticoagulation testing than all other brands combined.

About Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.

All trademarks used or mentioned in this release are protected by law.

Siemens DCA HbA1c Test Achieves CE Mark

The Siemens Healthcare Diagnostics, Tarrytown, NY, DCA HbA1c test kit, already used to monitor diabetes patients’ HbA1c levels, has achieved the CE mark as an aid to diagnose diabetes and identify patients at risk for developing the disease. Available for use on the company’s DCA systems, including the DCA Vantage® Analyzer, the test kit now provides clinicians with a streamlined solution that delivers fast, actionable results for the diagnosis and management of diabetes in environments ranging from physicians offices to hospitals and clinics.

HbA1c testing can be conducted at any time and requires no preparation by the patient, unlike fasting plasma glucose (FPG) measurements, where fasting must occur at least eight hours prior to testing. Also, HbA1c testing only requires a single measurement as opposed to blood glucose testing that involves serial blood draws over several hours.

With the Siemens DCA HbA1c test, only a small (1 µL) whole blood finger stick sample is needed, enabling clinicians to identify at-risk patients within minutes, review test results and discuss early intervention and disease management options during the same office visit. By reducing the need for follow-up visits, in-office testing of HbA1c with the Siemens DCA HbA1c kit not only helps consolidate operations, but also contributes to improved patient care through a simple-to-use tool.

FDA warns Braintree Laboratories about bugs in its laxatives

By Brian Benson

The Patriot Ledger

Posted May 19, 2010 @ 07:34 PM

Last update May 20, 2010 @ 08:31 AM

The Food and Drug Administration has issued a second warning to Braintree Laboratories after insects were discovered in some of its products.

The FDA received 21 complaints from consumers who found insects, insect parts and spiders in five products made by the Braintree-based company at its Holbrook manufacturing facility, according to a May 10 letter to the company from John R. Marzilli, district director for the New England District of the FDA in Stoneham.

FDA investigations in December and January identified significant violations of Current Good Manufacturing Practice regulations at the pharmaceutical company, which makes gastrointestional drugs including the laxative MiraLax.

Braintree Laboratories failed to determine if “facility or raw material quality problems were at the root of these complaints,” Marzilli wrote.

The company previously told the FDA it would increase pest control monitoring, look for trends among complaints and determine the origin of the insects.

But, the FDA also wants Braintree Laboratories to submit a plan for determining additional potential contamination sources and audit its raw materials and packaging suppliers.

“FDA considers contamination of finished drug products with foreign material (e.g., insects) a significant product quality issue,” Marzilli wrote.

Officials from Braintree Laboratories were unavailable for comment Wednesday, a company operator said.

The company has 15 working days upon receipt of the letter to tell the FDA what they are doing to correct the violations or seek an extension. If they fail to act, Braintree Laboratories could face product seizure, injunctions, or withholding of future product approval requests.

FDA officials examine each situation on a case-by-case basis to determine what penalties are imposed, said Mary Yebba, public affairs specialist for the FDA’s New England District.

Brian Benson may be reached at bbenson@ledger.com.

Copyright 2010 The Patriot Ledger. Some rights reserved

Can the FDA streamline the approval process and deliver medicines to patients? (click here) Washington Post.