MicroScan Negative Panels Recall Issued Due to False Results

Roughly 78,000 microbiology testing panels were recalled last month, after the manufacturer recognized that the devices may report false results that could cause a delay in therapy or administering of inappropriate antibiotics.  

On September 4, the FDA determined that a Siemens MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels recall should be considered a Class I medical device recall, the most serious recall classification. The panels were originally recalled on August 21, when Siemens sent out an Urgent Field Safety Notice after learning the devices may show false results for imipenem and moropenem.

The microbiology testing panels are used to detect infections. False results could lead to patients being prescribed the wrong antibiotics or result in delays in treatment.

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The recall includes Synergies plus Negative following models and identification numbers; Urine Combo1 with part number 10444745 and part number B1025-106, combo 2 with material number 10444747 and part number B1025-108, Breakpoint Combo 7 with material number 10444748 and part number B1025-109, urine combo 2 with material number 10444749 and part number B1025-112, and Urine Combo 5 with material number 10483101 and part number B1025-115.

The recalled products were manufactured by Siemens Healthcare Diagnostics Inc., of West Sacramento, California and were distributed throughout the US between July 11, 2011 and August 2, 2013.

On August 21, 2013, Siemens sent out an Urgent Field Safety Notice to all affected customers identifying the products defect, problem, and the actions to be taken. Customers who have received this letter are encouraged to confirm their receipt of the Safety Notice and return the Field Correction Effectiveness Check Sheet.

Class I recalls are the highest level of recall because there is a reasonable probability that the use of the product will cause serious adverse health consequences including death.

In addition, Siemens is recommending customers to review previous test results and schedule routine follow-ups as they continue to monitor readings. Customers may contact Siemens at 1-800-677-7226 for further questions and concerns about the recall.


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