HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetri
FDA device recall Z-0086-2014 · posted 2013-10-25 · Terminated
Recall details
- Recalling firm
- HemoCue AB
- Reason for recall
- HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.
- Action taken
- HemoCue sent an Urgent Field Safety Notice dated July 24, 2013. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Quarantine any HemoCue Urine Albumin (110608); lot numbers 1208848 to 1304847 you may have in your possession 2. Return the Field Safety Notice Verification Form to: fax: 562-668-5794 We apologize for the inconvenience this advisory has caused you. Please feel free to contact Technical Support at 800-426-7256 with any questions.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KQO
- Quantity affected
- 10,356 boxes/50 microcuvettes
- Distribution
- Worldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and W
- Date initiated
- 2013-07-16
- Date posted
- 2013-10-25
- Date terminated
- 2014-04-28
- 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 |