Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Internal Number - B1025-112 Catalog Number - 10444749 Lot code/expiration date: 2012-07-12, 2012-07-12; 2012-10-03, 2012-10-03; 2013-06-08, 2013-06-08; 2013-12-17, 2013-12-17; 2014-04-22, 2014-04-22; 2014-06-11, 2014-06-11;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Healthcare Diagnostics, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Product Codes/Lot Numbers:
Internal Number - B1025-112 Catalog Number - 10444749 Lot code/expiration date: 2012-07-12, 2012-07-12; 2012-10-03, 2012-10-03; 2013-06-08, 2013-06-08; 2013-12-17, 2013-12-17; 2014-04-22, 2014-04-22; 2014-06-11, 2014-06-11;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2122-2013
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The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
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Siemens Healthcare Diagnostics
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.