VITROS Chemistry Products COCM Reagent
FDA device recall Z-0817-2014 · posted 2014-01-23 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Inaccurate quality control results.
- Action taken
- On October 4, 2013 Ortho Clinical Diagnostics issued a Product Correction Notification to customers via US Postal Service Priority Mail or FedEx regarding VITROS Chemistry Products COCM Reagent due to inaccurate quality control results. Ortho Clinical Diagnostics advised their customers to discontinue use and discard any recalled product. OCD customers with questions should be contact Customer Technical Services at 1-800-421-3311.
- Root cause
- Other
- Status
- Terminated
- Product code
- DIO
- Quantity affected
- 3,342 units
- Distribution
- Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colom
- Date initiated
- 2013-10-04
- Date posted
- 2014-01-23
- Date terminated
- 2018-05-17
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062123) | Ortho-Clinical Diagnostics, Inc. | 2006-11-16 |