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Pointe Ethyl Alcohol Level 2 Control (300 mg/dL)

HORIBA INSTRUMENTS INCORPORATED · Model 60-EA0450-5 · UDI-DI 00811727017437

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

Description

Pointe Ethyl Alcohol Level 2 Control (300 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Controls are for use as assayed quality control materials to monitor the precision of the Pointe Ethyl Alcohol Reagent Set (Ref# 60-EA0440-100/60-EA0440-1L) on a number of automated clinical chemistry analyzers.

Recalls

DateFirmReason
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

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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.