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NATtrol™

ZEPTOMETRIX CORPORATION · Model NATtrol™ BV Positive Control · UDI-DI 01220000260238

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510(k) clearances

Adverse events

Recalls

Facilities

Description

NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

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.