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MDx-Chex for BC-GN

STRECK, INC. · Model 250080 · UDI-DI 00844509002437

PMN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteus spp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

Recalls

Date	Firm	Reason
2019-05-16	Microbiologics Inc	Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
2019-04-09	Microbiologics Inc	Product with incorrect shelf life.
2019-04-09	Microbiologics Inc	Product with incorrect shelf life.
2019-01-31	Microbiologics Inc	Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

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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.