Recall Class: Class I
Date Recall Initiated: August 21, 2013
Products: Siemens Material Number / Part Number
- Synergies plus Negative Urine Combo 1- 10444745 / B1025-106
- Synergies plus Negative Combo 2 - 10444747 / B1025-108
- Synergies plus Negative Breakpoint Combo 7 - 10444748 / B1025-109
- Synergies plus Negative Urine Combo 2 - 10444749 / B1025-112
- Synergies plus Negative Urine Combo 5 - 10483101 / B1025-115
This recall covers 78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.
Use: MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels are used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria.
Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento, CA 95691-3427
Reason for Recall: MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System. This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.
Siemens Healthcare Diagnostics, Inc. at 1-800-677-7226 Option 1 (USA/Canada)
FDA District: San Francisco
Siemens sent an Urgent Field Safety Notice dated August 21, 2013, to all affected customers. The letter identified the defective products, problem and actions to be taken. The letter instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing.
Customers are further asked to confirm receipt of the Safety Notice by returning a Field Correction Effectiveness Check Sheet by fax to (302) 631-8467. In addition, an Important Product Information notice will be added to products manufactured in future kits.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.