—#173293

Product

Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K051650
Affected lot / code info: Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019

Why it was recalled

Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On May 29, 2019, Siemens issued Urgent Medical Device Correction notices to U.S.A. customers via FedEx courier service and Urgent Field Safety Notices to international customers via email. Actions to be Taken by the Customer: 1. Do not use TestPaks within 2 mos of expiration. 2. Repeat samples with cTNL results above 0.07 ng/mL or your institution's established 99th percentile value. 3. Complete and return the Field Correction Effectiveness Check form 4. Retain a copy of the letter with your laboratory records and forward a copy of the notice to anyone to whom you may have distributed the product. Siemens is working to resolve this issue and will contact customers when additional information is available. Siemens will reimburse users for repeat tests and discarded cTNL TestPaks within 2 months of the printed expiration date associated with this field corrective action.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2019-05-29
Terminated: 2022-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173293. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.