| Date Initiated by Firm |
July 16, 2019 |
| Date Posted |
August 23, 2019 |
| Recall Status1 |
Terminated 3 on April 30, 2021 |
| Recall Number |
Z-2361-2019 |
| Recall Event ID |
83416 |
| 510(K)Number |
K081338
|
| Product Classification |
Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
|
| Product |
Roche Elecsys Anti-CCP Immunoassay
Catalog # 07251670190 |
| Code Information |
Lot # 376648 Exp : 08/31/2019 Lot # 388800 Exp : 09/30/2019 Anti-CCP assay: Anti-CCP Elecsys E2G 100 The affected lots of Anti-CCP have been distributed 02/28/2019 through 07/01/2019. ***Updated 7/17/20*** Current (in-date) and future lots of both Catalog numbers are impacted. In-date lots: 461913, exp 7/31/2020 467132, exp 9/30/2020 |
Recalling Firm/
Manufacturer |
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
Roche Support Network Support Center
800-428-2336
|
Manufacturer Reason
for Recall |
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
¿ Customers will be instructed to only use serum samples when testing with one of the affected lots numbers.
¿ Re-measure the sample if an implausible result occurs while using plasma samples, and a high Anti-CCP result does not match the patients clinical picture.
¿ To follow the work-around provided in the UMDC concerning pre-analytical sample handling for plasma samples.
¿ Perform maintenance according to the operator manual (e.g., Liquid Flow Cleaning [LFC]) to ensure proper functioning of the analyzer or module.
¿ Customers will be reminded that sample quality can be affected by fibrin clots and how this significantly impacts the Anti-CCP results.
Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
***Updated 7/17/20***
An updated letter was sent out to customers on July 13, 2020. After further investigation, Roche has decided to remove human plasma as a sample type from the intended use and remove all claims associated with the plasma sample type. The change is applicable for all current and upcoming lots.
Customer actions required:
" Use the Elecsys Anti-CCP assay with serum samples only for all current and future Elecsys Anti-CCP lot
numbers.
" ALL customers, complete the response form included with the letter and return to the firm
" If you cannot run serum samples in your laboratory, complete the Product Information section of the response form to obtain reagent credit or contact your Roche sales representative for further options.
" If your facility has distributed the affected product to another site, please ensure this UMDC is provided to
that site.
" File this UMDC for future reference.
" Discard Urgent Medical Device Correction TP-00714 if you previously received it. |
| Quantity in Commerce |
135 units |
| Distribution |
AZ
CA
FL
HI
IA
IL
IN
KY
LA
MA
MI
MO
MT
NJ
NY
OK
OR
PA
PR
SC
TX
VA |
| 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 = NHX and Original Applicant = Roche Diagnostics
|
