FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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
- Recall number
- Z-1103-2008
- Recalling firm
- Abbott Laboratories
- 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
- Status
- Terminated
- Initiated
- 2007-12-19
- Posted
- 2008-05-14
- Terminated
- 2008-07-02
- Reason
- Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 51749i2, 51754i2 and 56675i2.
- 510(k) numbers
- K051215, K961439
- PMA numbers
- not on file
- Product code
- GGK
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28