Home › BECTON, DICKINSON AND COMPANY › BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit
BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit
BECTON, DICKINSON AND COMPANY · Model 220143 · UDI-DI 00382902201434
LSL
Prescription
1
510(k) clearances
192
Adverse events
7
Recalls
28
Facilities
Description
Swab Wet Male Urethral
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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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.