Chiron Diagnostics Corporation Acs: Centaur Br Immunoassay

510(k) K982680

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK982680	Date15 Oct 1998Cleared	StatusActive

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 — FDA 510(k) Active

510(k)