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Terminated

CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

FDA Recall Z-0527-06 · Posted 2006-02-16

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2005-12-16
Date Terminated2006-04-13
Product Quantity871 units

Reason for Recall

T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

Firm Action

The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.

Root Cause

Other

Distribution Pattern

Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010953CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAYAbbott Laboratories · 2001-06-06

Official Source

View FDA Recall →

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

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