Recall Z-1112-2014— Remel Inc

Name: FDA recall Z-1112-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2014-01-24, terminated 2014-07-23. It names one FDA 510(k) clearance: K831469. Product: Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.. Reason: The product may contain high levels of microbial contamination.

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Terminated: 2014-07-23
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, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.

Reason for recall

The product may contain high levels of microbial contamination

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