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Control, Hemoglobin
FDA product code GGM · Class 2 · Hematology
76
Registered devices
2
Adverse events
2
Recalls
15
510(k) clearances
Devices with this code
Eurotrol — Eurotrol B.V.InteliQ — BIO-RAD LABORATORIES, INC.DiaSpect Control Pack HBT4 — DiaSpect Medical GmbHEurotrol — Eurotrol B.V.Lyphochek — BIO-RAD LABORATORIES, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.HemoTrol Duo — Eurotrol B.V.Hemoglobin Control Solution — Urit Medical Electronic Co., Ltd.CueSee® CO-OX — Eurotrol B.V.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Eurotrol — Eurotrol B.V.Liquichek — BIO-RAD LABORATORIES, INC.CueSee® CO-OX — Eurotrol B.V.HemoTrol WB — Eurotrol B.V.AIMSTRIP HEMOGLOBIN CONTROL SET — GERMAINE LABORATORIES, INCDade® Sickle-Trol Hemoglobin Controls — Siemens Healthcare Diagnostics Products GmbHResearch and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Liquichek — BIO-RAD LABORATORIES, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.HemoTrol WB — Eurotrol B.V.DiaSpect Control HBT2 — EKF-diagnostic GmbHLiquichek — BIO-RAD LABORATORIES, INC.Liquichek — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-10-18 | EUROTROL INC | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
| 2018-10-18 | EUROTROL INC | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
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