Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents
FDA device recall Z-0619-2013 · posted 2012-12-28 · Terminated
Recall details
- Recalling firm
- HemoCue AB
- Reason for recall
- Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
- Action taken
- HemoCue sent an "IMPORTANT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Correction Notification Verification Form was included for customers to complete and return. Contact the firm at 562-668-5741 for questions regarding this notification.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JIQ
- Quantity affected
- 48 affected analyzers
- Distribution
- Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
- Date initiated
- 2012-11-07
- Date posted
- 2012-12-28
- Date terminated
- 2013-03-14
- Location
- Angelholm, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (K053253) | Hemocue AB | 2006-02-17 |