Recall Z-0466-2015
Remel Inc · initiated October 23, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: DR0800M box lot 1316151, Exp. 30Sep2014
Reason for recall
A reagent within the test may return false negative results.
FDA-determined cause: Other
Action taken
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).
Details
- Recall number
- Z-0466-2015
- Initiated
- October 23, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- January 22, 2015
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Quantity
- 59/50 test boxes
- Distribution
- Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
- Recalling firm
- Remel Inc, Lenexa, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0465-2015 Class II | Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box.…A reagent within the test may return false negative results. | 10/23/2014Terminated |