| Class 2 Device Recall Elecsys CA 199 |  |
Date Initiated by Firm | February 07, 2020 |
Date Posted | March 05, 2020 |
Recall Status1 |
Terminated 3 on May 30, 2024 |
Recall Number | Z-1444-2020 |
Recall Event ID |
84915 |
510(K)Number | K050231 |
Product Classification |
System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
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Product | Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer |
Code Information |
Lot 416245
***Updated 10/5/20***
483123
***Updated 8/5/22***
Additional released lots are subject to the same workaround:
46449, 50474,525510, and 568976
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Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact | Roche Customer Support Center 800-428-2336 |
Manufacturer Reason for Recall | The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On February 7, 2020, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers were informed of the product issue and given two options for CA 19-9 testing until another reagent lot is available for the cobas e 801 module: 1) Use a different Roche platform for testing, or 2) Implement a workaround, described in detail in the customer letter. The letter also provided instructions for receiving credit depending on which option was elected.
Roche will notify customers when a new lot of CA 19-9 reagent for the cobas e 801 is available for ordering.
***Updated 10/5/20***
On 10/2/20, the firm issued an updated letter to customers to communicate an expansion to the recall. An additional lot was added to the recall scope. |
Quantity in Commerce | 684 |
Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI. |
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 = NIG
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