Microscan Synergies Plus Negative Breakpoint Combo 7 recall
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For…
Why was Microscan Synergies Plus Negative Breakpoint Combo 7 recalled?
Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Internal Number B1025-109, Catalog Number - 10444748 Lot code/expiration date: 2012-08-17, 2012-08-17; 2012-10-06, 2012-10-06; 2012-12-08, 2012-12-08; 2013-01-09, 2013-01-09; 2013-03-02, 2013-03-02; 2013-04-12, 2013-04-12; 2013-06-15, 2013-06-15; 2013-08-06, 2013-08-06; 2013-09-24, 2013-09-24; 2013-12-07, 2013-12-07; 2014-01-08, 2014-01-08; 2014-01-31, 2014-01-31; 2014-03-25, 2014-03-25; 2014-05-09, 2014-05-09; 2014-07-01, 2014-07-01.
- Product
- Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4319 boxes, 86, 380 panels
- Distribution
- Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.
- Recall date
- September 18, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)