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Medical Device Recalls
Class 2 Recall
VARIANT ®-thalassemia Short Program

See Related Information
Date Recall
Initiated		 March 18, 2008
Date Posted September 11, 2008
Recall Number Z-1588-2008
Product VARIANT ?-thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with ?-thalassemia ROM card lot PA 62600, PIN 2700104
Code Information Lot number 70080440
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules , California 94547-1803
Reason For
Recall		 Some product ROM cards have an incorrect program loaded and are unable to be updated.
Action The firm initiated its recall on March 18, 2008 by issuing a recall notice to customers and subsidiaries via e-mail. Not all VARIANT ®-Thalassemia Short ROM Cards are affected. Inventory should be examined and quarantine the product subject to this Recall. Contact your regional Bio-Rad office for ROM Card replacement or if you have questions.
Quantity in Commerce 64 kits total
Distribution Product was distributed to 17 consignees and 7 subsidiaries Worldwide. Distribution included to states of CA, TX, WI, VA, UT, PA, TN, OH, FL, MA, OR, AR, IL, MD, CO, and NY, and countries of UK, Australia, Canada, France, Singapore, New Zealand, Italy.
 

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