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.
Reported: December 3, 2014 Initiated: October 23, 2014 #Z-0466-2015
Product 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.
Reason for Recall
A reagent within the test may return false negative results.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 59/50 test boxes
- Distribution
- Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Remel Inc. Units affected: 59/50 test boxes.
Why was this product recalled? ▼
A reagent within the test may return false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0466-2015.
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