VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: V
FDA device recall Z-1193-2014 · posted 2014-03-12 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
- Action taken
- On 1/22/2014, Customer Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. On 1/22/2014, Distributor Letters were sent via US Postal Service Priority Mail and/or FedEx overnight courier to US distributor consignees and instructed them to notify their consignees of the issue and actions.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 1554 units domestically
- Distribution
- Nationwide
- Date initiated
- 2014-01-15
- Date posted
- 2014-03-12
- Date terminated
- 2017-04-03
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS (K121608) | Ortho-Clinical Diagnostics, Inc. | 2013-02-15 |