Device product
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Z-1707-2015
Product summary
- Event
- Event 71176
- Status
- Terminated
- Classification
- Class III
- Quantity
- Domestic: 898 units
- Official record key
device-enforcement:Z-1707-2015
Official wording
Reason: The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Code information: Lot 3082, expiry date 7/27/2015
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.