Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00630414194707 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

9 recalls · 3 ongoing · FDA

3 recalls, same reason
- Ongoing Z-2425-2021 FDA Class II initiated 6 Jul 2021
- Ongoing Z-2426-2021 FDA Class II initiated 6 Jul 2021
- Ongoing Z-2424-2021 FDA Class II initiated 6 Jul 2021
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
3 recalls, same reason
- Terminated Z-1748-2017 FDA Class II initiated 8 Mar 2017
- Terminated Z-1747-2017 FDA Class II initiated 8 Mar 2017
- Terminated Z-1749-2017 FDA Class II initiated 8 Mar 2017
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
2 recalls, same reason
- Terminated Z-0507-2013 FDA Class II initiated 14 Nov 2012
- Terminated Z-0512-2013 FDA Class II initiated 14 Nov 2012 on shared 510(k) K982680
Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
- Terminated Z-0162-2013 FDA Class II initiated 11 Sep 2012
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — GUDID listing Listed

GUDID

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