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ARK™ Methotrexate Calibrator

ARK DIAGNOSTICS INC · Model 5026-0002-00 · UDI-DI 00858724003117

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the ARK™ Methotrexate Assay. The calibrators consist of a synthetic protein matrix and the levels are 0.00 umol/L, 0.05 umol/L, 0.15 umol/L, 0.25 umol/L, 0.50 umol/L and 1.2 umol/L.

Recalls

Date	Firm	Reason
2023-04-14	Ortho-Clinical Diagnostics, Inc.	Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
2014-02-06	Lin-Zhi International Inc	Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards t
2011-11-11	Microgenics Corp	Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range.
2011-06-08	Microgenics Corp	Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
2010-09-13	Abbott Laboratories	The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.

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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.