Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016;
FDA device recall Z-1264-2015 · posted 2015-03-11 · Terminated
Recall details
- Recalling firm
- Richard-Allan Scientific Company
- Reason for recall
- The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
- Action taken
- Urgent Medical Device Recall letters sent to Richard Allan distributors and customers. The recall notification includes the reason for the voluntary recall, risk to health, product information and actions to be taken by the distributor/customer.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HZJ
- Quantity affected
- 132
- Distribution
- US, Canada and Europe
- Date initiated
- 2015-02-19
- Date posted
- 2015-03-11
- Date terminated
- 2016-01-12
- Location
- Kalamazoo, MI
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