| Date Initiated by Firm | October 09, 2017 |
|---|
| Create Date | February 12, 2018 |
|---|
| Recall Status1 |
Terminated 3 on February 13, 2018 |
| Recall Number | Z-0592-2018 |
|---|
| Recall Event ID |
78910 |
| 510(K)Number | K121710 |
|---|
| Product Classification |
Dna-reagents, neisseria - Product Code LSL
|
| Product | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157.
Is a qualitative in vitro real-time PCR test. |
|---|
| Code Information |
Lot numbers: 25718, 25719, 25725, and 25727. |
Recalling Firm/
Manufacturer |
Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
|
| For Additional Information Contact |
408-541-4191 |
|---|
Manufacturer Reason
for Recall | Cepheid has received reports that some of our customers have experienced a higher number of
temperature drift errors than would typically be expected when using this test and its intended use
specimen types. Investigation of the issue also revealed an occasional probability of false
negative results which remains consistent with package insert claims. |
|---|
FDA Determined
Cause 2 | Equipment maintenance |
|---|
| Action | An Urgent Medical Device Recall letter (response form included), dated October 9, 2017, was sent to affected consignees. The letter identified the affected product, the issue involved, impact, and actions to be taken. Cepheid will provide replacement product for Xpert CT/NG assay product identified in this recall. Customers are to complete and the return the Response Form provided in order to receive replacement product. Additionally, the letter instructs users to review their laboratory statistics to see if their positivity rates are trending low during use of the affected lots. If so, they are to review the negative patient results according to their laboratory's Quality Management System. Customers are to refer to the applicable contact information provided if there are any questions. |
|---|
| Quantity in Commerce | 3,586 kits (49,400 units) |
|---|
| Distribution | Worldwide Distribution -- USA, Puerto Rico, and Haiti. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = LSL
|
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