Z-2797-2011

Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex...

Name: Z-2797-2011 Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex...
Creator: Sysmex America, Inc.
Published: 2009-06-23
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2009-06-23 / Terminated / root cause: manufacturing process

FDA source

Sysmex America, Inc. began a recall of 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... on 2009-06-23. The reason FDA records is "The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong...". 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-2797-2011
Status: Terminated
Initiated: 2009-06-23
Posted: 2011-07-13
Terminated: 2011-07-13
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 product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
Product code: GGK Products, Red-Cell Lysing Products
Reason for recall: The affected lots of Stromatolyser-IM lysing reagent was 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 tag: manufacturing process
FDA root cause: Environmental control
Action: Sysmex America, Inc. sent a "MEDICAL DEVICE RECALL" letter dated June 2009 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 at 800-218-2711. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the recall letter are directed to the Sysmex Technical Assistance Center at 1-888-879-7639. The firm sent a second notice to non-responding accounts on September 14, 2009. A copy of the June 26, 2009 recall letter and the fax back form were included with the letter. The customers were informed that Sysmex had not received their completed fax back form and were requested to respond to confirm the notification was received.
Quantity in commerce: 4,005 cubetainers
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.
Product codes and lots: Catalog number SIM-220A, lot numbers C9010, C9011, C9013, C9014, C9015, C9016 and C9017

Product code GGK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)