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Terminated

VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104

FDA Recall Z-1589-2008 · Posted 2008-09-11

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeJPD
Date Initiated2008-03-18
Date Terminated2009-11-10
Product Quantity64 kits total

Reason for Recall

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

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-Rad · 1993-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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