FDA Medical Device Recalls (openFDA)
Sysmex America, Inc.: Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.
- Recall number
- Z-3063-2011
- Recalling firm
- Sysmex America, Inc.
- Product
- Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.
- Status
- Terminated
- Initiated
- 2011-04-11
- Posted
- 2011-08-23
- Terminated
- 2012-03-14
- Reason
- The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.
- Root cause
- Process change control
- Action
- Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated April 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax to Sysmex Customer Service at 800-689-8296. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the notification are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.
- Quantity
- 1,887 cubetainers
- Distribution
- Worldwide Distribution--USA (nationwide and Puerto Rico) and the countries of Canada, Colombia, Ecuador, Mexico, Netherland Antilles and Peru.
- Lot, serial or model codes
- Catalog number SIM-220A, lot numbers Y0053, Y0054, Y0055
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GGK
- Firm FEI
- 1000515253
- Firm city
- Mundelein
- Firm state
- IL
- 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
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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