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ExtendSURE

CANTERBURY SCIENTIFIC LIMITED · Model HB110SCALAr · UDI-DI 09421902348044

JCM
10
510(k) clearances
2
Adverse events
1
Recalls
5
Facilities

Description

The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator which are prepared as a stabilized hemolysate from human blood. The calibrators are designed to establish known points of reference in laboratory testing procedures.

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

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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.