Device product
Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Z-1478-2013
Product summary
- Event
- Event 64164
- Status
- Terminated
- Classification
- Class III
- Quantity
- 201 units
- Official record key
device-enforcement:Z-1478-2013
Official wording
Reason: Affected products have a labeled expiration date of one year too long.
Code information: Product Code: CCM-9914; Lot: CCM-0281
Distribution pattern: Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
Derived failure modes
-
Unknown
Affected products have a labeled expiration date of one year too long.