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CDRH Consumer Article 1 T-SPOT.TB T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB). (Approved: 7/25/2008) Category: CDRH Consumer (Hits: 380 | Votes: 0 | Visited: 0 | Added: 2005-05-16 20:20:49) Write Review Rating Recommend : Print

Approved Devices 1 T-SPOT.TB T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB). (Approved: 7/25/2008) Category: CDRH Recently Approved Devices (Hits: 255 | Votes: 0 | Visited: 0 | Added: 2005-05-16 20:22:32) Write Review Rating Recommend : Print

Patient Safety Article 1 Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008) This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des... Category: FDA Patient Safety News (Hits: 229 | Votes: 0 | Visited: 0 | Added: 2005-05-16 20:23:44) Write Review Rating Recommend : Print

Press Release 1 FDA to Post Quarterly Report of Potential Safety Issues The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). Category: FDA Press Releases and Papers (Hits: 199 | Votes: 0 | Visited: 0 | Added: 2005-05-16 20:26:03) Write Review Rating Recommend : Print

Recalls Withdrawals and Alerts 1 Recall of Patak's Dopiaza Cooking Sauce (September 4) ACH Food Companies, Inc. is recalling its Patak's Dopiaza Cooking Sauce sold in the United States because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products. The product is distributed nationally through retail stores. ACH Food Companies is notifying its distributors and stores that carry this product that it contains an undeclared milk allergen and to immediately remove it from distribution. Category: FDA Recalls, Withdrawals and Alerts (Hits: 243 | Votes: 0 | Visited: 0 | Added: 2005-05-16 20:27:15) Write Review Rating Recommend : Print

Recalls Withdrawals and Alerts 2 Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5) Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts. Category: FDA Recalls, Withdrawals and Alerts (Hits: 233 | Votes: 0 | Visited: 0 | Added: 2005-05-16 20:28:42) Write Review Rating Recommend : Print