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.
Recall
- Recall Number
- Z-0466-2015
- Event Number
- 69566
- Firm
- Remel Inc
- FEI Number
- 1924669
- Product Code
- LIB
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 23, 2014
- Posted
- December 16, 2014
- Terminated
- January 22, 2015
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
Description
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.
A reagent within the test may return false negative results.
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).
Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
59/50 test boxes