Recalls / —
—#50534
Product
Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
- FDA product code
- JSI — Culture Media, Selective And Differential
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot 506069, Exp. 2007/03/20
Why it was recalled
False negative results for sorbitol fermenting bacteria such as E. Coli 0157.
Root cause (FDA determination)
Other
Action the firm took
Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.
Recalling firm
- Firm
- Remel, Inc.
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2007-02-21
- Posted by FDA
- 2007-03-14
- Terminated
- 2008-03-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #50534. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.