Events

Recall of Device Recall IMMULITE 2000/2500 Chemiluminescent Substrate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52206
  • Event Risk Class
    Class 2
  • Event Number
    Z-1891-2010
  • Event Initiated Date
    2009-05-15
  • Event Date Posted
    2010-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82515
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Discrete Photometric Chemistry Analyzer For Clinical Use - Product Code JJE
  • Reason
    These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.
  • Action
    An Urgent Field Safety Notice dated May 2009 was sent to consignees of record for the previously mentioned lots. The Notice advised the following: These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. Actions If you are using one of these lots with your instrument, please take the following actions: 1. Upon receipt of a non-affected substrate lot, discontinue using IMMULITE 2000/2500 Chemiluminescent Substrate. Prior to receiving a non-affected substrate lot, you can continue to use the affected substrate if you follow the Interim Procedure. 2. Discard all bottles of the affected Substrate lots remaining in your inventory once non-affected Substrate lots are available. 3. The first time ONLY that you switch from one of the affected substrate lots in Table 1 to a non-affected lot, you should follow the procedure and steps below during instrument Startup: a. Empty the substrate reservoir completely before adding the new lot. b. Prime the instrument to cleanse the lines of the previous lot of substrate. c. Add the new lot of substrate to the reservoir and prime the instrument again.* d. Adjust all methods run on that instrument. *Note: Prime the substrate line as instructed on Page 83, Priming the Substrate Probe, of the IMMULITE 2000/2500 Operators Manual Rev. A. 4. Discuss the contents of this letter with your laboratory director. 5. Complete the Completion Notification Form that accompanies this notice and return it as directed on the form. Submitting this form indicates that you have received the information in the Urgent Field Safety Notice and have either discarded all lots of the affected IMMULITE 2000/2500 Substrate, or are following the Interim Procedure while awaiting the receipt of a non-affected Substrate lot and will discard the affected lots as soon as the non-affected lots are received in your laboratory. Interim Procedure Siemens recognizes that you

Device

Device Recall IMMULITE 2000/2500 Chemiluminescent Substrate
  • Model / Serial
    Substrate lot L2SUBX 253 packed into Module L2SUBM 282 (EXP: 2010-07-31); Substrate lot L2SUBX 254 packed into Module L2SUBM 283 (EXP:2010-07-31); Substrate lot L2SUBX 255 packed into Module L2SUBM 284 (EXP: 2010-07-31); Substrate lot L2SUBX 256A packed into Module L2SUBM 288 (EXP:2010-08-31); Substrate lot L2SUBX 257A packed into Module L2SUBM 286 (EXP:2010-08-31); Substrate lot L2SUBX 258 packed into Module L2SUBM 285 (EXP: 2010-08-31); Substrate lot L2SUBX 259A packed into Module L2SUBM 287 (EXP: 2010-08-31).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    IMMULITE 2000/2500 Chemiluminescent Substrate Module || For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc., 5700 W 96th St, Los Angeles CA 90045-5544
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA