FDA Device Intelligence
Home › BIO-RAD LABORATORIES, INC. › Lyphochek

Lyphochek

BIO-RAD LABORATORIES, INC. · Model 553 · UDI-DI 00847661000884

JCM
1
510(k) clearances
2
Adverse events
1
Recalls
5
Facilities

Description

Lyphochek Hemoglobin A2 Control Bilevel (A human whole blood assayed Hemoglobin A2 control.)

Recalls

DateFirmReason
2016-11-07Tosoh Bioscience, Inc.The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at th

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.