Z-1103-2008

White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell...

Name: Z-1103-2008 White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell...
Creator: Abbott Laboratories
Published: 2007-12-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-12-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of 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... on 2007-12-19. The reason FDA records is "Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1103-2008
Status: Terminated
Initiated: 2007-12-19
Posted: 2008-05-14
Terminated: 2008-07-02
Recalling firm: Abbott Medical
Product: 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
Product code: GGK Products, Red-Cell Lysing Products
Reason for recall: Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
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.
Quantity in commerce: Product 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
Distribution: 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.
Product codes and lots: Lot Numbers: 51749i2, 51754i2 and 56675i2.

Product code GGK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)