Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.
- Company
- Genzyme Corporation
- Recall Initiated
- April 14, 2008
- Posted
- August 22, 2008
- Terminated
- September 16, 2008
- Recall Number
- Z-2148-2008
- Quantity
- 3,443
- Firm Location
- Cambridge, MA
Reason for Recall
Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
Distribution
Nationwide Distribution
Lot / Code Info
Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09
Root Cause
Nonconforming Material/Component
Action Taken
Genzyme notified accounts by Fed'X on 4/14/08 via an Imprtant Field Correction letter, requesting users to discard kits and follow the "User Update" instructions previously provided to minimize calibration error. Customers are to complere and sign the Confirmation of Notification form and fax it back to the firm regardless if they have any affected product or not. Also, requires that the customer confirms that the REagent OD limits for First and Last H are set at 0.15 for Lipase on the Olympus AU400/400e, AU600, AU640/640e and AU2700/AU5400 Systems.