Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the

FDA device recall Z-1232-2015 · posted 2015-03-02 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

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

Action taken

ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review all results reported using the recalled lot. The recalling firm requested the consignees complete and return the Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. If the affected lot was further distributed, the consignees were instructed to notify those entities of the recall and provide a copy of the recall notification letter. If you have any questions, please contact our Technical Services Department at 800.255.6730 (US) or 913.888.0939 ( International)

Root cause

Under Investigation by firm

Status

Terminated

Product code

JSK

Quantity affected

24 packs (10 x 100 ml vials)

Distribution

US Distribution to the states of : MI, ND, SC, TN, and TX.

Date initiated

2015-02-05

Date posted

2015-03-02

Date terminated

2017-02-13

Location

Lenexa, KS

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