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

FDA device recall Z-2797-2011 · posted 2011-07-13 · Terminated

Recall details

Recalling firm

Sysmex America, Inc.

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.

Action taken

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.

Root cause

Environmental control

Status

Terminated

Product code

GGK

Quantity affected

4,005 cubetainers

Distribution

Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.

Date initiated

2009-06-23

Date posted

2011-07-13

Date terminated

2011-07-13

Location

Mundelein, IL