ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology.
FDA Recall Z-0132-2010 · Posted 2009-11-09
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Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2009-07-17
Date Terminated2010-01-26
Product Quantity4,526
Reason for Recall
Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.
Firm Action
A product correction notice was issued to consignees on July 17, 2009. Field representatives were instructed to visit consignees, inspect cables and replace them
Root Cause
Other
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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