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Terminated

CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

FDA Recall Z-0639-2007 · Posted 2007-03-16

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGIF
Date Initiated2004-05-12
Date Terminated2007-05-01
Product Quantity6,893 units

Reason for Recall

Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

Firm Action

On May 12, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.

Root Cause

Other

Distribution Pattern

Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961439ABBOTT CELL-DYN 4000 SYSTEMAbbott Diagnostics · 1996-10-18

Official Source

View FDA Recall →

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

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