Severity
Moderate
FDA Devices recall · Reported April 30, 2014
A reagent contained within the product may return false negative results.
Remel Inc recalled Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box conta… - a moderate-severity action.
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box conta… was recalled by Remel Inc in April 30, 2014. Reason: A reagent contained within the product may return false negative results.. Check the official notice for the remedy. Verify recall #Z-1474-2014 with the FDA Devices before acting.
The recall
Remel Inc issued this moderate-severity FDA Devices recall-A reagent contained within the product may return false negative results..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1474-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1474-2014) was formally reported on April 30, 2014, with the manufacturer initiating the action on March 17, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Remel Inc is listed as the recalling firm, operating out of Lenexa, KS. Federal records list the affected scope as 2/50-test boxes.
The documented reason for this recall is: A reagent contained within the product may return false negative results. Distribution data in the federal record shows the product reached: Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
2/50-test boxes
Related Recalls
6
3 from same agency
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
A reagent contained within the product may return false negative results.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1474-2014 |
| Date reported | April 30, 2014 |
| Date initiated | March 17, 2014 |
| Recalling firm | Remel Inc |
| Firm location | Lenexa, KS |
| Affected scope | 2/50-test boxes |
| Distribution | Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 30, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.