ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antib
FDA device recall Z-1596-2010 · posted 2010-05-19 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostics International, Ltd.
- Reason for recall
- There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.
- Action taken
- Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.
- Root cause
- Pending
- Status
- Terminated
- Product code
- LOL
- Quantity affected
- 1,326
- Distribution
- Nationwide Distribution -- Including Puerto Rico.
- Date initiated
- 2009-12-30
- Date posted
- 2010-05-19
- Date terminated
- 2011-08-31
- Location
- Barceloneta, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT HAVAB-M (K063329) | Abbott Laboratories | 2007-04-16 |