Genzyme Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Genzyme Corporation
Lot Codes / Batch Numbers
Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09
Products Sold
Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09
Genzyme Corporation is recalling Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containi due to Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the k. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026