Skip to content

Atellica IM CKMB Master Curve Material, Cat No. 10995534 recallZ-0117-2019 · Siemens Healthcare Diagnostics, Inc · initiated Jul 24, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-0117-2019
Status
Terminated
Initiated by the company
Jul 24, 2018
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
2 sets
Product code
JHS
FDA submissions
K962126
Distribution
US Nationwide Distribution

Product description

Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

Code information (models, lots, serial numbers)

SMN 10995534  Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under K962126 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80954).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page