Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva

510(k) K973628

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK973628	Date13 Mar 1998Cleared	StatusActive

5 recalls · 2 ongoing · FDA

- Ongoing Z-0547-2020 FDA Class II initiated 15 Nov 2018
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
- Ongoing Z-2558-2019 FDA Class II initiated 18 Jan 2016
Instrument stopped working due to a software lockup, and no patient results are produced.
3 recalls, same reason
- Terminated Z-0154-2020 FDA Class II initiated 10 Jan 2012
- Terminated Z-0156-2020 FDA Class II initiated 10 Jan 2012
- Terminated Z-0155-2020 FDA Class II initiated 10 Jan 2012
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

1 jurisdiction

United States — FDA 510(k) Active

510(k)