Recalls / —
—#159632
Product
CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
- FDA product code
- JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K802498
- Affected lot / code info
- Lot 1865331, Exp. 06/2021
Why it was recalled
Product may have incorrect cation information detailed on the product label.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The recalling firm issued letters dated 11/2/2017 via regular mail on 11/2/2017 notifying the customer of the incorrect labeling information and providing them the correct labeling information.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- Distribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.
Timeline
- Recall initiated
- 2017-11-02
- Terminated
- 2020-08-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #159632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.