—#167106

Product

ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

FDA product code: JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K962126
Affected lot / code info: SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211

Why it was recalled

A potential bias was identified with certain kits compared to the internal standards.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2018-07-24
Terminated: 2020-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167106. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.