Recall Z-2149-2008 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Genzyme Corporation
Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
| Date | Aug 22, 2008 (initiated Apr 14, 2008) |
| Status | Terminated |
| Reason | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 3,443 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K897150 | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT Toyo Jozo Co., Ltd., Feb 26, 1990 |