D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mo
FDA device recall Z-1676-2015 · posted 2015-05-26 · Terminated
Recall details
- Recalling firm
- Biocare Medical, LLC
- Reason for recall
- Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
- Action taken
- Biocare Medical sent a Medical Device Notification letter dated May 6, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete all actions listed on the enclosed Return Response Form.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- NJT
- Quantity affected
- 19 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
- Date initiated
- 2015-05-06
- Date posted
- 2015-05-26
- Date terminated
- 2015-06-04
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.