Recall Z-0951-2013 ยท GJT Plasma, Coagulation Factor Deficient
Diagnostica Stago, Inc.
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay
| Date | Mar 14, 2013 (initiated Jan 28, 2013) |
| Status | Terminated |
| Reason | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. |
| Root cause | Software design (manufacturing process) |
| Action | Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800- |
| Quantity | 2901 kits |
| Distribution | Worldwide Distribution - USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962675 | STA - LIATEST VWF TEST KIT American Bioproducts Co., Oct 25, 1996 |