Sysmex America Inc: 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).

Recall number

Z-0100-2014

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).

Status

Terminated

Initiated

2013-05-15

Posted

2013-10-18

Terminated

2016-08-15

Reason

The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.

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

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.

Lot, serial or model codes

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

510(k) numbers

["K032677"]

PMA numbers

not on file

Product code

GKZ

Firm FEI

3009711478

Firm city

Lincolnshire

Firm state

IL

Firm country

not on file

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

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