VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzy
FDA device recall Z-2232-2014 · posted 2014-08-14 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- Reason for recall
- Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.
- Action taken
- A recall letter was issued on 4/17/2013 to US customers via FED Ex mailing. The letter included a fax back acknowledgment form. A recall notice was also sent via email to bioMerieux Subsidiaries and international distributors on 4/11/2013.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DAP
- Quantity affected
- 2160 units
- Distribution
- AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY
- Date initiated
- 2013-04-17
- Date posted
- 2014-08-14
- Date terminated
- 2014-10-08
- Location
- Marcy L'Etoile, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS D-DIMER EXCLUSION II (DEX2) (K112818) | bioMerieux, Inc. | 2012-07-31 |