Food, drugs, devices › Remel Inc
Device recall: Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com
FDA enforcement event 63555 is a device recall by Remel Inc of Lenexa, KS, initiated 21 Aug 2012 and classified Class II, with 1 product record.
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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 4 Jun 2013. 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 firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt."
Distribution
"Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0790-2013 | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used… | 30 | Class II | Terminated | 13 Feb 2013 |
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 firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt."
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: "Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Jun 2013. "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.