FDA Medical Device Recalls (openFDA)
Genzyme Corporation: Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
- Recall number
- Z-2151-2008
- Recalling firm
- Genzyme Corporation
- Product
- Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
- Status
- Terminated
- Initiated
- 2008-04-14
- Posted
- 2008-08-22
- Terminated
- 2008-09-16
- 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
- Lot, serial or model codes
- Reagent lot Number 491686, Lot #7EPP31 exp 01/15/09
- 510(k) numbers
- ["K897150"]
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 1221955
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28