Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on
FDA device recall Z-0538-2014 · posted 2013-12-18 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- The product may give weak or false negative test results.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JTO
- Quantity affected
- 109 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-05-02
- Date posted
- 2013-12-18
- Date terminated
- 2014-03-12
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STREPTEX ZL01 (K842828) | Wellcome Diagnostics | 1984-08-15 |