Food, drugs, devices › Remel Inc
Device recall: Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm nam
Remel Inc (Lenexa, KS) initiated this device recall on 24 Jan 2014; FDA lists 1 product record under event 67415, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 23 Jul 2014. Initiation: voluntary: firm initiated. Remel Inc has 50 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Remel Inc, Lenexa, KS.
Reason for recall
"The product may contain high levels of microbial contamination"
Distribution
"US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1112-2014 | 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… | 44/10/500-ml. vial boxes | Class II | Terminated | 5 Mar 2014 |
Context
Other enforcement events for Remel Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The product may contain high levels of microbial contamination"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.