RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 30762 32470 33999 35395 36284 39672 40405 40456 40508 30779 33198 34000 35462 37243 39688 40406 40460 40509 30784 33201 34082 35688 37261 39689 40407 40461 40510 30819 33232 34083 35690 37275 39690 40408 40464 40512 30841 33370 34291 35692 37292 39691 40409 40466 40561 30842 33438 34427 35693 37295 39692 40410 40467 40562 30844 33459 34438 35703 37296 39693 40411 40468 40565 30846 33573 34442 35705 37563 39694 40412 40469 40568 30904 33640 34444 35922 38110 39695 40413 40470 40576 30905 33643 34627 36003 38138 39698 40421 40471 40580 30906 33863 35002 36005 38306 39699 40422 40473 40582 30907 33865 35009 36006 38815 39700 40427 40477 40583 31006 33968 35053 36007 39301 39701 40436 40489 40594 31771 33986 35055 36008 39303 39702 40437 40501 40596 31772 33997 35195 36113 39459 39703 40448 40502 40612 32356 33998 35393 36116 39597 40403 40451 40503 40616 40624 40625 40642 40643 40644 40647 40648 40666 40669 40677 40678 40679 40748 40806 313388
- 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:
- Potential Patient Demographic Error with Blank Patient ID Field
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306
Product Codes/Lot Numbers:
Serial Numbers: 30762 32470 33999 35395 36284 39672 40405 40456 40508 30779 33198 34000 35462 37243 39688 40406 40460 40509 30784 33201 34082 35688 37261 39689 40407 40461 40510 30819 33232 34083 35690 37275 39690 40408 40464 40512 30841 33370 34291 35692 37292 39691 40409 40466 40561 30842 33438 34427 35693 37295 39692 40410 40467 40562 30844 33459 34438 35703 37296 39693 40411 40468 40565 30846 33573 34442 35705 37563 39694 40412 40469 40568 30904 33640 34444 35922 38110 39695 40413 40470 40576 30905 33643 34627 36003 38138 39698 40421 40471 40580 30906 33863 35002 36005 38306 39699 40422 40473 40582 30907 33865 35009 36006 38815 39700 40427 40477 40583 31006 33968 35053 36007 39301 39701 40436 40489 40594 31771 33986 35055 36008 39303 39702 40437 40501 40596 31772 33997 35195 36113 39459 39703 40448 40502 40612 32356 33998 35393 36116 39597 40403 40451 40503 40616 40624 40625 40642 40643 40644 40647 40648 40666 40669 40677 40678 40679 40748 40806 313388
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2040-2017
Related Recalls
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
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.
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;
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.
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
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.