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Terminated

CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

FDA Recall Z-0708-2007 · Posted 2007-04-03

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGIF
Date Initiated2006-04-17
Date Terminated2007-11-28
Product Quantity56,075 units

Reason for Recall

High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

Firm Action

On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites

Root Cause

Other

Distribution Pattern

Worldwide Distribution-USA including states of AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV and Countriers of Argentina, Australia, Brazil, Hong Kong, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051215CELL-DYN SAPPHIRE SYSTEMAbbott Laboratories · 2005-07-21K961439ABBOTT 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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