FDA Medical Device Recalls (openFDA)
Remel Inc: Oxoid Legionella Pneumo Groups 2-14, DR0802M, 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.
- Recall number
- Z-1474-2014
- Recalling firm
- Remel Inc
- Product
- Oxoid Legionella Pneumo Groups 2-14, DR0802M, 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.
- Status
- Terminated
- Initiated
- 2014-03-17
- Posted
- 2014-04-18
- Terminated
- 2014-12-11
- Reason
- A reagent contained within the product may return false negative results.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.
- Quantity
- 2/50-test boxes
- Distribution
- Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
- Lot, serial or model codes
- DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIB
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28