🔍 RecallPedia

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

Class I - Dangerous
🏥 Medical Devices Recalled: October 9, 2020 Primus Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Product Name and Product Code ultra2 Resolution Variants Analyzer / 03-01-0047 ultra2 Resolution Analytical Column / 01-05-0011 Resolution Analytical Column / 01-05-0015 FASC Position Marker / 01-04-0042 A2+F Control Material Kit / 01-04-0043 Mobile Phase 1 Reagent 3.8L / 01-03-0040 Mobile Phase 1 Reagent 940mL / 01-03-0042 Mobile Phase 2 Reagent 3.8L / 01-03-0041 Mobile Phase 2 Reagent 940mL / 01-03-0044 2 Diluent Reagent 3.8L / 01-03-0056 2 Diluent Reagent 940mL / 01-03-0059 System Wash Reagent / 01-03-0035 Analyzer Unit serial numbers: 100242 100314 100331 100354 100468 100541 100638 100746 100243 100316 100332 100355 100485 100551 100639 100747 100244 100317 100334 100356 100492 100558 100644 100751 100245 100319 100335 100357 100501 100559 100645 100758 100300 100321 100337 100358 100503 100561 100654 100765 100301 100322 100338 100359 100507 100562 100660 100802 100304 100323 100342 100360 100508 100563 100664 100305 100324 100343 100361 100510 100572 100666 100306 100325 100344 100404 100515 100574 100683 100309 100326 100345 100411 100518 100587 100729 100310 100327 100348 100416 100527 100590 100730 100312 100329 100351 100427 100531 100627 100743 100313 100330 100353 100446 100533 100633 100745
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Primus Corporation
Reason for Recall:
The product did not receive pre-market approval or clearance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

Product Codes/Lot Numbers:

Product Name and Product Code ultra2 Resolution Variants Analyzer / 03-01-0047 ultra2 Resolution Analytical Column / 01-05-0011 Resolution Analytical Column / 01-05-0015 FASC Position Marker / 01-04-0042 A2+F Control Material Kit / 01-04-0043 Mobile Phase 1 Reagent 3.8L / 01-03-0040 Mobile Phase 1 Reagent 940mL / 01-03-0042 Mobile Phase 2 Reagent 3.8L / 01-03-0041 Mobile Phase 2 Reagent 940mL / 01-03-0044 2 Diluent Reagent 3.8L / 01-03-0056 2 Diluent Reagent 940mL / 01-03-0059 System Wash Reagent / 01-03-0035 Analyzer Unit serial numbers: 100242 100314 100331 100354 100468 100541 100638 100746 100243 100316 100332 100355 100485 100551 100639 100747 100244 100317 100334 100356 100492 100558 100644 100751 100245 100319 100335 100357 100501 100559 100645 100758 100300 100321 100337 100358 100503 100561 100654 100765 100301 100322 100338 100359 100507 100562 100660 100802 100304 100323 100342 100360 100508 100563 100664 100305 100324 100343 100361 100510 100572 100666 100306 100325 100344 100404 100515 100574 100683 100309 100326 100345 100411 100518 100587 100729 100310 100327 100348 100416 100527 100590 100730 100312 100329 100351 100427 100531 100627 100743 100313 100330 100353 100446 100533 100633 100745

Distribution:

Distributed in: US, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0321-2021