—#108536

Product

MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.

FDA product code: JWY — Manual Antimicrobial Susceptibility Test Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K862140
Affected lot / code info: lot code 2011-07-22.

Why it was recalled

Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.

Root cause (FDA determination)

Process control

Action the firm took

Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

Distribution pattern: Worldwide Distribution -- US, Turkey, Poland, and Great Britain.

Timeline

Recall initiated: 2011-06-16
Posted by FDA: 2012-05-08
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.