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Atellica CH 930 Analyzer recallZ-0581-2020 · Siemens Healthcare Diagnostics, Inc. · initiated Sep 23, 2019

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

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

FDA root cause category: Software design

What the company is doing

Siemens issued an Urgent medical Device Correction, (UMDC ASW19-06.A.US) and Urgent Field Safety Notification (UFSN ASW19-06.A.OUS) to all affected Customers via Certified Mail (domestic) and e-mail (international) beginning on 2019-09-23. It included the following instructions to the user: Actions to be Taken by the Customer 1. Do not order Reagent Pack Calibration (C0 Adjust) while the Reagent Lot calibration is in progress. 2. Always run QC after calibration before running patient samples. If QC is ordered with calibration and it recovers out of range high, the calibration status will be 'Awaiting Acceptance'. Reject and re-order the calibration. - Please review this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - If you have received any complaints of illness or adverse events associated with the product listed immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.

Recall details

Recall number
Z-0581-2020
Status
Terminated
Initiated by the company
Sep 23, 2019
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1432
Product code
JJE
FDA submissions
K151767
Distribution
Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK ZA ES SE CH TW TH TR AE GB UY VN.

Product description

Atellica CH 930 Analyzer

Code information (models, lots, serial numbers)

SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163

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 K151767 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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