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Control, Hemoglobin
FDA product code GGM · Class 2 · Hematology
80
Registered devices
2
Adverse events
2
Recalls
15
510(k) clearances
Devices with this code
DiaSpect Control HBT1 — EKF-diagnostic GmbHEurotrol — Eurotrol B.V.HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL) — RANDOX LABORATORIES LIMITEDDiaSpect Control HBT2 — EKF-diagnostic GmbHCueSee® CO-OX — Eurotrol B.V.CueSee® CO-OX — Eurotrol B.V.McKesson — MCKESSON MEDICAL-SURGICAL INC.HemoTrol WB — Eurotrol B.V.Liquichek — BIO-RAD LABORATORIES, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.CueSee® CO-OX — Eurotrol B.V.McKesson — MCKESSON MEDICAL-SURGICAL INC.Eurotrol — Eurotrol B.V.Hemoglobin Control Solution — Urit Medical Electronic Co., Ltd.CueSee® CO-OX — Eurotrol B.V.Liquichek — BIO-RAD LABORATORIES, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.HemoTrol Duo — Eurotrol B.V.Hemoglobin Control Solution — Urit Medical Electronic Co., Ltd.CueSee® CO-OX — Eurotrol B.V.CueSee® CO-OX — Eurotrol B.V.Liquichek — BIO-RAD LABORATORIES, INC.CueSee® CO-OX — Eurotrol B.V.
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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