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NATtrol™
ZEPTOMETRIX CORPORATION · Model NATtrol™ BV Negative Control · UDI-DI 01220000260245
PMN
Prescription
10
510(k) clearances
1
Adverse events
4
Recalls
10
Facilities
Description
NATtrol™ BV Negative Control (NATBVNEG-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 Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus 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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Get your free API keyRead the docsData 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.