Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Ca
FDA device recall Z-0448-2009 · posted 2009-01-06 · Terminated
Recall details
- Recalling firm
- Catch Incorporated
- Reason for recall
- A high homocysteine level can be reported as falsely low.
- Action taken
- On 01/18/07 an "URGENT: PRODUCT CORRECTIVE ACTION" letter was sent to the consignees. The letter states the circumstances in which a high homocysteine rate can result in a false low homocysteine rate, a work around for the problem which a flag must be programmed into the user defined homocysteine test parameters and instructions to advise their customers about the situation was addressed in the letter so the consignees can take the recommended corrective action. A confirmation sheet was included with the letter to be signed by a representative of each distributor and returned to Catch Inc. Contact Catch Inc. at 1.425.402.8960 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LPS
- Quantity affected
- 2,699 kits
- Distribution
- CA and PA.
- Date initiated
- 2007-01-18
- Date posted
- 2009-01-06
- Date terminated
- 2010-09-28
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011689) | Catch, Inc. | 2001-07-25 |
| HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011692) | Intersect Systems, Inc. | 2001-07-25 |