Class 2 Device Recall Roche Diagnostics Tinaquant Myoglobin Gen.2.

• Date Initiated by Firm: July 02, 2019
• Create Date: August 30, 2019
• Recall Status: Terminated on October 22, 2021
• Recall Number: Z-2445-2019
• Recall Event ID: 83351
• 510(K)Number: K061683
• Product Classification: Myoglobin, antigen, antiserum, control - Product Code DDR
• Product: The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
• Code Information: Lot: 349860 and onward
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: SAME; 317-521-4343
• Manufacturer Reason for Recall: The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.
• FDA Determined Cause: Under Investigation by firm
• Action: Roche issued the Urgent Medical Device Correction (UMDC) on July 2, 2019 via UPS (signature required), to the consignee. The letter address the problem, health risk and action to take: Instructions provided to manually implement an Extra Wash Cycle (EWC) for the applicable system. If customers have another validated system not impacted by this issue, (i.e. cobas Integra 400 plus) in their lab, it can be used as an alternative for the Tina-quant Myoglobin Gen.2 assay rather programming the special wash.As a long-term solution, Roche will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. Instruction will be provided to complete the attached fax form. 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. The UMDC will also be available on diagnostics.roche.com. Update: Updated UMDC (TP-00708 version 2) and Fax Back Form (TP-00737) was posted to the diagnostics.roche.com website on 8/2, and mailed to customers on 8/5. The Urgent Medical Device Correction has been updated to include an additional consignee instruction to run the Tina-quant Myoglobin Gen.2 assay in batch mode along with the already implemented Extra Wash Cycles on the cobas c 501 and 502 modules.
• Quantity in Commerce: 4,309 (cobas c311-340 units;cobas c501-3,517 units;cobas c502 452 units
• Distribution: Nationwide
• 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 = DDR