Z-1945-2016Class II

The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended...

Name: Z-1945-2016 The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended...
Creator: Sysmex Corporation
Published: 2014-12-18
License: https://open.fda.gov/license/

Sysmex Corporation / initiated 2014-12-18 / Terminated / root cause: design

FDA source

Sysmex Corporation began a recall of The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient... on 2014-12-18. FDA classified it as Class II and gives the reason as "There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1945-2016
Classification: Class II
Status: Terminated
Initiated: 2014-12-18
Posted: 2016-06-10
Terminated: 2016-07-25
Recalling firm: Sysmex Corporation
Product: The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Root cause tag: design
FDA root cause: Device Design
Action: Sysmex Corporation sent a Product Notification Field Correction letter were to all affected customers of record. The letters included instructions for customers to: 1) Review results with an unexpected increase in Hgb, MCH, MCHC, and/or PLT-I. The increase may result in a low or normal value being artificially elevated to either a normal result or a result above the reference ranges, or a high value being artificially increased. There is negligble impact to the RBC when the issue occurs; 2) The relationship with an elevated Hgb would cause the indices (MCH and MCHC) values to appear to be abnormally elevated and may result in the results being flagged for verification or indicated to be outside of reference ranges; 3) Review any "Turbidity/Hgb Interf?" flag which will automatically trigger at an MCHC of 37.5 g/dL; 4) If Hgb is affected, the PLT-I may be also. Review any PLT-I result when an unexpected increase in MCH/MCHC or "Turbidity/Hgb Interf?" flag occurs; 5) Gross interference is likely to trigger a flag, however there is a potential any interference could increase the Hgb or the PLT-I count from a lower level to an "normal" level. Follow laboratory protocol for confirming unexpected results. Customers were further advised that they will be contacted by a Sysmex Field Representative within 180 days to schedule an appointment to replace the rinse cup on the analyzer(s) and that version 00-16 software will be installed to change the rinsing sequence for the aspiration probe. Customers with questions are requested to e-mail the Sysmex Technical Assistance Center. Urgent questions can be answered by calling the Technical Assistance Center at 888-879-7639 (24 hours a day / 7 days a week).
Quantity in commerce: 1,137 units (US) 54 units (Canada) 9 inventory
Distribution: Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.
Product codes and lots: 1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484; 2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10

Product code GKZ

K112605Class IISysmex Xn-SeriesSysmex America, Inc. / cleared 2012-10-19

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)