FDA Medical Device Recalls (openFDA)
Remel Inc: Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
- Recall number
- Z-0537-2014
- Recalling firm
- Remel Inc
- Product
- Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
- Status
- Terminated
- Initiated
- 2013-05-02
- Posted
- 2013-12-18
- Terminated
- 2014-03-12
- Reason
- The product may give weak or false negative test results.
- Root cause
- Process control
- Action
- ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.
- Quantity
- 768 kits
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot 1192181, exp. January 2014
- 510(k) numbers
- ["K842828"]
- PMA numbers
- not on file
- Product code
- JTO
- 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