Recall Z-0100-2014— Sysmex America Inc

Name: FDA recall Z-0100-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-15

Class II · Terminated

Class II FDA medical device recall by Sysmex America Inc, initiated 2013-05-15, terminated 2016-08-15. It names one FDA 510(k) clearance: K032677. 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).. Reason: The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number..

Recalling firm: Sysmex America Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Terminated: 2016-08-15
Firm location: Lincolnshire, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K032677 — SYSMEX POCH-100ISysmex America, Inc.·cleared 2004-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.