FDA Medical Device Recalls (openFDA)
Remel Inc: Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
- Recall number
- Z-2057-2014
- Recalling firm
- Remel Inc
- Product
- Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
- Status
- Terminated
- Initiated
- 2014-06-11
- Posted
- 2014-07-15
- Terminated
- 2014-08-28
- Reason
- Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
- Root cause
- Employee error
- Action
- The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.
- Quantity
- 76/50-bottle boxes
- Distribution
- Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
- Lot, serial or model codes
- Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10
- 510(k) numbers
- ["K032306"]
- PMA numbers
- not on file
- Product code
- MDB
- 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