Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIA
FDA device recall Z-0951-2013 · posted 2013-03-14 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
- Action taken
- 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 800-725-0607.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- GJT
- Quantity affected
- 2901 kits
- Distribution
- Worldwide Distribution - USA and Canada.
- Date initiated
- 2013-01-28
- Date posted
- 2013-03-14
- Date terminated
- 2013-07-19
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STA - LIATEST VWF TEST KIT (K962675) | American Bioproducts Co. | 1996-10-25 |