Recall Z-0216-2024— Cepheid

Name: FDA recall Z-0216-2024
Creator: U.S. Food and Drug Administration
Published: 2023-04-24

Class II · Ongoing

Class II FDA medical device recall by Cepheid, initiated 2023-04-24. It names one FDA 510(k) clearance: K172126. Product: Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,. Reason: pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results..

Recalling firm: Cepheid
Classification: Class II
Status: Ongoing
Initiated: 2023-04-24
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K172126 — Xpert Xpress Strep ACepheid·cleared 2017-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

Reason for recall

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.