Recall Z-1400-2017— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2017-02-09, terminated 2019-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,. Reason: Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-09
- Terminated
- 2019-05-01
- Firm location
- Lenexa, KS, United States
Product description
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Reason for recall
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Data sourced from openFDA. This site is unofficial and independent of the FDA.