HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human Ig
FDA device recall Z-1764-2008 · posted 2008-08-17 · Terminated
Recall details
- Recalling firm
- Focus Diagnostics Inc
- Reason for recall
- A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
- Action taken
- Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LGC
- Quantity affected
- Lot Code 063169 - 97 Kits, Lot Code 063354 - 16 Kits, Lot Code 063355 - 74 Kits
- Distribution
- Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.
- Date initiated
- 2007-07-06
- Date posted
- 2008-08-17
- Date terminated
- 2009-06-25
- Location
- Cypress, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (K000238) | Mrl Diagnostics | 2000-04-14 |