Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm nam

FDA device recall Z-1112-2014 · posted 2014-02-26 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

The product may contain high levels of microbial contamination

Action taken

Thermo Fisher sent an Urgent Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please notify any personnel who need to be aware of the potential for false presumptive Legionella spp. identification or masking of the recovery/isolation of Legionella spp. Review your inventory for the affected product and discard it. You should review results reported using these lots and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If you have further distributed these product lots, please contact those entities, advise them of the situation and provide them with a copy of this letter. You should insert your contact information, email, and fax numbers in the acknowledgement form and request that they return it to you. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

JSK

Quantity affected

44/10/500-ml. vial boxes

Distribution

US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.

Date initiated

2014-01-24

Date posted

2014-02-26

Date terminated

2014-07-23

Location

Lenexa, KS

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