FDA Medical Device Recalls (openFDA)
Remel Inc: PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
- Recall number
- Z-2351-2015
- Recalling firm
- Remel Inc
- Product
- PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
- Status
- Terminated
- Initiated
- 2015-06-30
- Posted
- 2015-08-07
- Terminated
- 2017-02-13
- Reason
- A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
- Root cause
- Under Investigation by firm
- Action
- On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.
- Quantity
- 4420 bottles
- Distribution
- Nationwide Distribution, including Puerto Rico and the country of Canada.
- Lot, serial or model codes
- lot 1463129, exp. date 31 May 2016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTY
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06