—#130965

Product

Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

FDA product code: LIB — Device, General Purpose, Microbiology, Diagnostic
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: DR0800M box lot 1316151, Exp. 30Sep2014

Why it was recalled

A reagent within the test may return false negative results.

Root cause (FDA determination)

Other

Action the firm took

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).

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.

Timeline

Recall initiated: 2014-10-23
Posted by FDA: 2014-12-16
Terminated: 2015-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.