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Aptima®

Hologic, Inc. · Model APTIMA CONTROLS KIT, IVD · UDI-DI 15420045506237

LSL QEP NSU MKZ Prescription

510(k) clearances

192

Adverse events

Recalls

Facilities

Description

The Aptima® Controls Kit is for use with the Aptima® Assays for the detection of C. trachomatis and/or N. gonorrhoeae. These quality control reagents are to be used according to the instructions in the package insert of the appropriate Aptima® Assay to establish run validity.

Recalls

Date	Firm	Reason
2017-10-09	Cepheid	Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its i
2015-07-27	Cepheid	Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
2015-07-27	Cepheid	Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
2005-01-10	Becton Dickinson & Co.	An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
2004-07-07	Roche Molecular Systems Inc	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
2004-07-07	Roche Molecular Systems Inc	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
2003-07-21	Becton Dickinson & Co.	Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

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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.