Date Initiated by Firm | July 24, 2018 |
Create Date | October 15, 2018 |
Recall Status1 |
Terminated 3 on May 26, 2020 |
Recall Number | Z-0114-2019 |
Recall Event ID |
80954 |
510(K)Number | K962126 |
Product Classification |
Differential rate kinetic method, cpk or isoenzymes - Product Code JHS
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Product | ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. |
Code Information |
SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
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For Additional Information Contact | 508-668-5000 |
Manufacturer Reason for Recall | A potential bias was identified with certain kits compared to the internal standards. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On July 24, 2018 Siemens Healthineers issued Urgent Medical Device Recall notices to U.S. customers and Urgent Field Safety Notices to OUS customers.
The following are Actions to be Taken by the Customer:
Customers using ADVIA Centaur CKMB Calibrator Lots ending in 64:
- Review the notice with your Medical Director.
- Review your inventory of these products and immediately order replacement ADVIA Centaur CKMB Calibrator kit lots ending in 68 by completing the Field Correction Effectiveness Check Form attached to the letter.
- You may continue use of ADVIA Centaur CKMB Calibrator kit lots until
replacement product is received in your laboratory.
- Upon receipt of replacement product in your laboratory, discontinue use of and discard the ADVIA Centaur CKMB Calibrator kit lots listed in Table 1 of the letter.
- ADVIA Centaur CKMB Calibrator kit lots ending in 63 may continue to be used until the assigned expiration date.
- Refer to the Additional Information section for expected patient sample bias when transitioning to ADVIA Centaur CKMB Calibrator kit lots ending in 68.
Customers using ADVIA Centaur Master Curve Material:
- Discontinue use of and discard the ADVIA Centaur MCM lots in Table 1.
- Review your inventory of these products and order replacement ADVIA Centaur CKMB Master Curve Material by completing the Field Correction Effectiveness Check Form attached to the letter.
- Utilize ADVIA Centaur CKMB MCM Lot 13384 and future lots.
- Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.
Customers using Atellica IM CKMB Calibrator Lots ending in 66:
- Review your inventory of these products and immediately order replacement Atellica IM CKMB Calibrator kit lots ending in 69 by completing the Field Correction Effectiveness Check Form attached to the letter.
- You may continue use of Atellica IM CKMB Calibrator kit lots in Table 1 until replacement product is received in your laboratory |
Quantity in Commerce | 69 kits |
Distribution | US Nationwide Distribution |
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 = JHS
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