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April 28, 2004
Company: Tri-Med Laboratories IncProduct: “PSE Carbinoxamine DM Syrup,” “Carbodex DM Syrup,” “Ronddamine DM Syrup” and other drugs Date: 4/28/04 Your investigation report for failing Pediahist lot F312 indicates that the batch was formulated superpotent because the manufacturing order sheet was reproduced from another product format on a computer, hence the incorrect amounts of ingredients were...
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Company: Gyrus Medical, IncDate of Enforcement Report: 4/28/04 Class: II PRODUCT Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04. REASON The generator may malfunction when used in close proximity to a monopolar generator. CODE Model 744000....
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Company: Abbott Laboratories, Inc.Date of Enforcement Report: 4/28/04 Class: II PRODUCT ARCHTECT System RS-232 Manual, product list number 06F71- 04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module. Recall # Z-0818-04. REASON When using a LIS the software system will send up a test result of up to 20 characters although...
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