Recall Z-2531-2023— Remel, Inc
Class II · Ongoing
Class II FDA medical device recall by Remel, Inc, initiated 2023-08-14. It names one FDA 510(k) clearance: K871447. Product: remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora. Reason: On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples.
- Recalling firm
- Remel, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-14
- Firm location
- Lenexa, KS, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Reason for recall
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Data sourced from openFDA. This site is unofficial and independent of the FDA.