Recall Z-1561-2021— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2021-04-22, terminated 2023-08-08. It names one FDA 510(k) clearance: K972359. Product: Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.. Reason: The media allows growth of E. faecalis ATCC 29212 with blackening of the media..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-22
- Terminated
- 2023-08-08
- 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 Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Reason for recall
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Data sourced from openFDA. This site is unofficial and independent of the FDA.