HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
FDA device recall Z-0101-2014 · posted 2013-10-29 · Terminated
Recall details
- Recalling firm
- HemoCue AB
- Reason for recall
- HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
- Action taken
- On 8/13/2013 the firm sent Field Safety Notices to their customers.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- GKR
- Quantity affected
- 42,330 packages/4 boxes/25 microcuvetes
- Distribution
- Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, W
- Date initiated
- 2013-07-25
- Date posted
- 2013-10-29
- Date terminated
- 2014-08-11
- 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 HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 (K032203) | Hemocue, Inc. | 2003-08-25 |