Bd Facs Sample Prep Assistant Iii

• • Terminated Z-2358-2020 FDA Class II ·initiated 8 Jul 2019

  The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

510(k) Number

K131301 ↗

FDA Product Code

PER

Device Class

Class I

Regulation

21 CFR Part 862.2750

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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