Z-0465-2015Class II

Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a...

Name: Z-0465-2015 Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a...
Creator: Remel Inc
Published: 2014-10-23
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-10-23 / Terminated

FDA source

Remel Inc began a recall of Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L... on 2014-10-23. FDA classified it as Class II and gives the reason as "A reagent within the test may return false negative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0465-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Posted: 2014-12-16
Terminated: 2015-01-22
Recalling firm: Remel Inc
Product: Oxoid Legionella Pneumo Groups 2-14 Latex Test, 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, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.
Product code: LIB Device, General Purpose, Microbiology, Diagnostic
Reason for recall: A reagent within the test may return false negative results.
FDA root cause: Other
Action: ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in commerce: 2/50 test boxes
Distribution: Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
Product codes and lots: DR0802M box lot 1301909, Exp. 30Sep2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0465-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0465-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0466-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25

Product code LIB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)