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Urine Calibrator Set

Chromsystems Instruments + Chemicals GmbH · Model 69039 · UDI-DI 04250317536754

DNN
7
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities

Description

6PLUS1® Multilevel Urine Calibrator Set MassChrom® Ethyl Glucuronide, Ethyl Sulfate

Recalls

DateFirmReason
2010-07-26Hospira, Inc.The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin.
2008-03-27EMD Chemicals IncIncorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.

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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.