FDA Medical Device Recalls (openFDA)
Catch Incorporated: Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
- Recall number
- Z-0921-2012
- Recalling firm
- Catch Incorporated
- Product
- Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
- Status
- Terminated
- Initiated
- 2011-06-27
- Posted
- 2012-01-27
- Terminated
- 2012-07-11
- Reason
- Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.
- Root cause
- Nonconforming Material/Component
- Action
- Catch Inc. sent an "URGENT-PRODUCT RECALL" letter dated 27 June 2011 to one sole customer. The letter described the product, problem, and actions to be taken by the customer. A reply form was attached to the letter for the customer to complete and return via fax at 425-402-8954. Please contact the firm at 425-402-8960 for questions regarding this recall.
- Quantity
- 47 kits
- Distribution
- Product distributed in PA.
- Lot, serial or model codes
- Lot D1101303
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPS
- Firm FEI
- 3005002431
- Firm city
- Bothell
- Firm state
- WA
- 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