| Date Initiated by Firm |
December 17, 2018 |
| Create Date |
January 29, 2019 |
| Recall Status1 |
Terminated 3 on April 10, 2020 |
| Recall Number |
Z-0784-2019 |
| Recall Event ID |
81823 |
| 510(K)Number |
K093955
|
| Product Classification |
Hepatitis a test (antibody and igm antibody) - Product Code LOL
|
| Product |
Anti-HAV IgM test System, Material No. 11820591160
Product Usage:
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
|
| Code Information |
APP-file version 04.10-101 on the cobas e 602 module. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
800-428-2336
|
Manufacturer Reason
for Recall |
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
|
FDA Determined
Cause 2 |
Software Design Change |
| Action |
Roche issued URGENT MEDICAL DEVICE CORRECTION notices and Fax Forms dated 12/17/2018 to customers via UPS courier service.
**Actions to be Taken by Customers/Users Currently Using APP-file Version 04.10 - 101**
1. If your LIS host stores the interpretation and COI information for Anti-HAV IgM, all COI results in the gray zone of 0.90 1.10 should be reviewed. Implement the following action for all gray zone results:
If discrepant interpretation of results is suspected, re-testing may be advisable in concordance with the recommendations in the assay method sheet and relevant clinical information.
2. Review the APP-file version downloaded for the Anti-HAV IgM application. The most current
APP-file version is (05.30 - 402). Download this version of the APP-file for the Anti-HAV IgM assay.
You can determine the APP-file version for Anti-HAV IgM currently installed on your cobas e 602 module by going to Utility > Application > Select Anti-HAV IgM test > Analyze tab, bottom right corner of the screen.
**Actions Required**
- Follow the instructions provided in the Actions to be Taken by Customers/Users Currently Using APP-file Version 04.10 - 101
- Confirm your cobas e 602 module is using APP-file 05.30 - 402. If it is not, immediately update to APP-file 05.30 - 402.
- Complete all sections of the fax form (TP-00518) and fax it to 1-855-207-2758 or email it to 6189roche@stericycle.com.
- File the Urgent Medical Device Correction for future use.
Customers with questions please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 |
| Quantity in Commerce |
70,639 units |
| Distribution |
US Nationwide Distribution |
| 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 = LOL and Original Applicant = Roche Diagnostics
|
