VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use
FDA device recall Z-1470-2014 · posted 2014-04-17 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
- Action taken
- The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter (Ref. CL14-086; dated March 5, 2014) via FedEx Overnight Courier and/or US Postal Service Priority Mail (for PO Boxes only) to its US consignees (OCD Direct, Drop-Ship and US Federal Government). In addition, OCD proactively communicated with the 3 affected customers via phone to inform them of the potential issue and expedite product replacement. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue using and discard all remaining inventory of VITROS CRBM Slides, Lot 3920-0800-8403; review previously reported results using this lot; discuss any concerns regarding previously reported results with their Laboratory Medical Director or with the requesting physician; complete the attached Confirmation of Receipt form no later than March 14, 2014; and forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- KLT
- Quantity affected
- 20 units
- Distribution
- US Distribution to states of: IN, MD, and TN.
- Date initiated
- 2014-03-05
- Date posted
- 2014-04-17
- Date terminated
- 2017-02-28
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283) | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-02-25 |