—#82515

Product

IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K970227
Affected lot / code info: 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).

Why it was recalled

These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc.
Address: 5700 W 96th St, Los Angeles, California 90045-5544

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-05-15
Posted by FDA: 2010-06-24
Terminated: 2011-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82515. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.