Reported Nov 6, 2013 · Terminated
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1…
Sysmex America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America Inc · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- 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 includeWBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO)
- Lot codes and dates
- Product Code023-1861-8
- Serial Numbers
B1677 - B1826F1827 - F2161F2178 - F2198F2216 - F2396F2411 - F2452F2464 - F2472F2495 - F2523F2533F2550 - F2560F2592 - F2601F2614 - F2635F2640 - F2648F2662 - F2679F2710 - F2853F2855 - F2871F2878 - F2922F2945F2946F2962 - F2970F2998 - F3008F3072 - F3080F3083 - F3098
- Amount recalled
- 193 units
Where it was sold
Why it was recalled
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
This product could cause temporary or reversible health problems — stop using it.
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