Day

May 20, 2009
Recipient: Mainline Technology, Inc Product: Mainline Confirms Strep A, Mainline Confirms Strep A Dots, FYI hCG Urine One-step Pregnancy Test, Mainline Confirms hCG One-step Pregnancy Test, Mainline Confirms III hCG One-Strep Pregnancy Test, and Mainline hCG Accuracy Check pos+ and neg- controls. Date: 1/23/09 Our inspection revealed that these devices are adulterated under section 501(f)(1)(B)...
Read More
Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 5/20/2009 Class:ll PRODUCT Centricity TriWin Laboratory Information System; The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval....
Read More
Company: Draeger Medical, IncDate of Enforcement Report 5/20/2009 Class:ll PRODUCT Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use. Catalog Numbers 5704757 and 5704758. Recall # Z-1263-2009 REASON The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a...
Read More
Company: Bio-Rad Laboratories, IncDate of Enforcement Report 5/27/2009 Class:ll PRODUCT Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000. Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus. Recall # Z-1395-2009 REASON The wrong barcode number and tube position number may be assigned...
Read More

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.