Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lots N1521417 N1522218 N1528917 N1526418 N1502518 N1527518 N1503218 N1529618 N1503918 N1530318 N1504618 N1531018 N1516318 N1531618 N1517218 N1532318 N1518318 N1535518 N1519418 N1536318 N1520118 ***new lots added 3/2/2020*** N1500119 N1520519 N1500219 N1521319 N1500620 N1522419 N1501119 N1523319 N1501520 N1526719 N1503519 N1527619 N1505619 N1528719 N1506419 N1529619 N1507919 N1533819 N1508519 N1534719 N1510619 N1535719 N1519019 N1530419 N1519719
  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:
Siemens Healthcare Diagnostics, Inc.
Reason for Recall:
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Product Codes/Lot Numbers:

Lots N1521417 N1522218 N1528917 N1526418 N1502518 N1527518 N1503218 N1529618 N1503918 N1530318 N1504618 N1531018 N1516318 N1531618 N1517218 N1532318 N1518318 N1535518 N1519418 N1536318 N1520118 ***new lots added 3/2/2020*** N1500119 N1520519 N1500219 N1521319 N1500620 N1522419 N1501119 N1523319 N1501520 N1526719 N1503519 N1527619 N1505619 N1528719 N1506419 N1529619 N1507919 N1533819 N1508519 N1534719 N1510619 N1535719 N1519019 N1530419 N1519719

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1421-2020

Related Recalls

Class I - Dangerous

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A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

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