一級召修 Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

(http://bme.freebbs.tw 醫學工程論壇同步發表)

Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

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 
  "西門子"革蘭氏陰性菌協同折點複合檢驗組七型 ＊＊＊ 衛署醫器輸字第023651號 ＊＊＊
• Synergies plus Negative Urine Combo 2 - 10444749 / B1025-112
  "西門子"革蘭氏陰性尿液協同快速複合板 2 型  ＊＊＊ 衛署醫器輸字第019938號 ＊＊＊
• Synergies plus Negative Urine Combo 5 - 10483101 / B1025-115
  "西門子"革蘭氏陰性尿液協同複合檢驗組五型  ＊＊＊ 衛署醫器輸字第023654號 ＊＊＊

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.

Recalling Firm: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.

使用的MicroScan的WalkAway系統配合 MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels 會出現不正確的中間亞胺培南(imipenem )和美羅培南(meropenem )藥敏試驗結果。這問題可能會導致不適當的抗生素治療或延遲啟動適當的治療時機。

Public Contact:Siemens Healthcare Diagnostics, Inc. at 1-800-677-7226 Option 1 (USA/Canada)

FDA District: San Francisco

FDA Comments: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.