VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITRO
FDA device recall Z-1707-2015 · posted 2015-06-04 · Terminated
Recall details
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Reason for recall
- The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
- Action taken
- On 5/06/2015, Customer Letter and Verification Form (Ref. CL15-095) were sent notifying the users of the issue and advised them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. On 5/06/2015, Distributor Letter (Ref. DL15-095) was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and actions. For questions,questions, please contact Customer Technical Services at 1-800-421-3311 at any time.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- CDP
- Quantity affected
- Domestic: 898 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-05-06
- Date posted
- 2015-06-04
- Date terminated
- 2017-09-13
- Location
- Bridgend, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |