FDA Device recall Z-1400-2017
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033
- FDA Device
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033 by Remel, citing test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1400-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-09 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Remel |
| Distribution | US |
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.
Identifiers
| code_info | A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1400-2017%22
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