Date Initiated by Firm | April 14, 2010 |
Date Posted | July 08, 2010 |
Recall Status1 |
Terminated 3 on January 26, 2012 |
Recall Number | Z-1970-2010 |
Recall Event ID |
55316 |
510(K)Number | K983886 |
Product Classification |
Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
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Product | Biokit HSV-2 Rapid test Catalogue Number: 3000-28001.
20 test Kit.
In Vitro Diagnostic test for Herpes Simplex Virus 2. |
Code Information |
Batch M691 (expiry: 2010/09) Batch M699 (expiry 2010/12) |
Recalling Firm/ Manufacturer |
Biokit U.S.A. Inc. 180 Hartwell Rd Bedford MA 01730-2443
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For Additional Information Contact | Rita Grueter 800-926-3353 |
Manufacturer Reason for Recall | Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Biokit USA notified US Customers by fax on 2/18/10 of the reason for the kit recall and requested to discard any remaining units. Accounts were advised to retest patients or review test results. Questions are directed to the firm at 800-926-3353. |
Quantity in Commerce | 192 kits |
Distribution | US (CA, FL, GA, IN, KY, MA, NY, VA) and UK |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LGC
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