Z-0100-2014Class II

pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1...

Name: Z-0100-2014 pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1...
Creator: Sysmex America Inc
Published: 2013-05-15
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2013-05-15 / Terminated / root cause: manufacturing process

FDA source

Sysmex America Inc began a recall of pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073... on 2013-05-15. FDA classified it as Class II and gives the reason as "The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number". 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-0100-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Posted: 2013-10-18
Terminated: 2016-08-15
Recalling firm: Sysmex America, Inc.
Product: pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
Product code: GKZ Counter, Differential Cell
Reason for recall: The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Sysmex, sent a "Product Notification-FIELD CORRECTION" letter dated May 2013 to all customers in the U.S. and Canada on May 15, 2013 by U.S. Mail. The letter describes the product, problem and actions to be taken. The customers will be contacted by a Sysmex Service Representative within the following 90 days to schedule an appointment to replace the Printed Circuit Board (PCB) on the internal printer. The repair will be performed during an on-site service visit. The customers were instructed to, until the repair can be made, use the thermal printer for reporting results; to compare the sample identification, values and decimal points on the printout with the data on the LCD screen for accuracy. If you have any questions concerning this information, please email the Sysmex Technical Assistance Center (TAC). Simply click on email TAC button on the home page of the CRC, complete the form that appears and then click the submit to send your question to TAC. Sending an email to TAC is recommended for non-urgent requests. For urgent request, call the Technical Assistance Center at 1-888-879-7639.
Quantity in commerce: 193 units
Distribution: Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
Product codes and lots: Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0100-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29

Product code GKZ

K032677Class IISysmex Poch-100ISysmex America, Inc. / cleared 2004-02-11

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)