Recall Z-1232-2015— Remel Inc

Name: FDA recall Z-1232-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-05

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2015-02-05, terminated 2017-02-13. It names one FDA 510(k) clearance: K831469. Product: Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.. Reason: Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Terminated: 2017-02-13
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 SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.

Reason for recall

Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.

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