Z-2148-2008

Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the...

Name: Z-2148-2008 Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the...
Creator: Genzyme Corporation
Published: 2008-04-14
License: https://open.fda.gov/license/

Genzyme Corporation / initiated 2008-04-14 / Terminated / root cause: manufacturing process

FDA source

Genzyme Corporation began a recall of 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 on 2008-04-14. The reason FDA records is "Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2148-2008
Status: Terminated
Initiated: 2008-04-14
Posted: 2008-08-22
Terminated: 2008-09-16
Recalling firm: Genzyme Corporation
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.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 3,443
Distribution: Nationwide Distribution
Product codes and lots: Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09

Product code CHI

K897150Class ILipase Color [Toyo] Serum Lipase Test KitToyo Jozo Co., Ltd. / cleared 1990-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)