Recall Z-1707-2015 ยท CDP Radioimmunoassay, Total Triiodothyronine
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
| Date | Jun 4, 2015 (initiated May 6, 2015) |
| Status | Terminated |
| Reason | The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels. |
| Root cause | Error in labeling |
| Action | 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 con |
| Quantity | Domestic: 898 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) Johnson & Johnson Clinical Diagnostics, Inc., Nov 27, 1996 |