FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.
- Recall number
- Z-2213-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.
- Status
- Terminated
- Initiated
- 2010-12-28
- Posted
- 2011-05-19
- Terminated
- 2012-06-04
- Reason
- The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and December 1, 2010 prior to completion of QC testing.
- Root cause
- Pending
- Action
- Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken. If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclosed response form within 10 days to acknowledge that they received this notice and are taking appropriate action. For the population at most risk, there is no serious consequences and only remote probability of injury and medically reversible consequences due by the small change for Hgb and WBC results. Consignees were also asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Technical questions regarding this Product Corrective Action were directed to Beckman Coulter Customer Service at( 800) -526-7694 in the United States and Canada.
- Quantity
- 1,296 units
- Distribution
- Worldwide Distrubution-- USA ( nationwide) including states of : AL, AR, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI, & WV and country of Canada.
- Lot, serial or model codes
- Lot Number: 101554F
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GGK
- Firm FEI
- 2050012
- Firm city
- Brea
- 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