FDA Medical Device Recalls (openFDA)
Remel Inc: 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.
- Recall number
- Z-1112-2014
- Recalling firm
- Remel Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-01-24
- Posted
- 2014-02-26
- Terminated
- 2014-07-23
- Reason
- The product may contain high levels of microbial contamination
- Root cause
- Unknown/Undetermined by firm
- Action
- 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).
- Quantity
- 44/10/500-ml. vial boxes
- Distribution
- US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
- Lot, serial or model codes
- Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015
- 510(k) numbers
- ["K831469"]
- PMA numbers
- not on file
- Product code
- JSK
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28