RecallDepth

VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104

Company
Bio-Rad Laboratories Inc
Recall Initiated
March 18, 2008
Posted
September 11, 2008
Terminated
November 10, 2009
Recall Number
Z-1588-2008
Quantity
64 kits total
Firm Location
Hercules, CA

Reason for Recall

Some product ROM cards have an incorrect program loaded and are unable to be updated.

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.

Lot / Code Info

Lot number 70080440

Root Cause

Mixed-up of materials/components

Action Taken

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.

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