Recalls / —
—#126296
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 Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
- FDA product code
- LIB — Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014
Why it was recalled
A reagent contained within the product may return false negative results.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
Timeline
- Recall initiated
- 2014-03-17
- Posted by FDA
- 2014-04-18
- Terminated
- 2014-12-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126296. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.