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Terminated

White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-1103-2008 · Posted 2008-05-14

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGGK
Date Initiated2007-12-19
Date Terminated2008-07-02
Product QuantityProduct was distributed in the follow amounts: 1,199 botttles of lot code 51749i2; 1,150 bottles of lot code 1574i2, 1,150 bottles of lot code 56675i2

Reason for Recall

Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

Firm Action

Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide Distribution including USA states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI and WV, and countries of: Argentina, Australia, Brazil, Canada, Germany, Hong Kong, Japan, Singapore, South Korea 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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