Recall Z-0578-2015— Remel Inc

Name: FDA recall Z-0578-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-13

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2014-11-13, terminated 2015-01-29. It names one FDA 510(k) clearance: K831469. Product: Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.. Reason: Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Terminated: 2015-01-29
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K831469 — LEGIONELLA CYE AGAR BASE & BCYE SUPPLOxoid U.S.A., Inc.·cleared 1983-06-08

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

Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.

Reason for recall

Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.

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